RTS 510(k) Review Experience

Recent Clearances – Updated as of June 14, 2024


eResearchTechnology GmbH | SpiroSphere, SpiroSphereECG, CardioSphere
Device Classification Name: calculator, predicted values, pulmonary function
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223629

Anqing Pukang Medical Technology Co., LTD. | Disposable Vinyl Examination Gloves
Device Classification Name: vinyl patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241252

Pollogen Ltd. | Legend X Applicator VO
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240999

Atraverse Medical | HOTWIRE™ RF Guidewire
Device Classification Name: catheter, septostomy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240900

Philips Medical Systems Technologies | Image Management V15
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240822

Infinite Biomedical Technology LLC | Glide (91000-GL-X)
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240884

Alembic, LLC | APRO 55 Catheter
Device Classification Name: catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234115

Kids-e-Dental LLP | e-SDF
Device Classification Name: diammine silver fluoride dental hypersensitivity varnish
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240619

SPM Medicare Pvt. Ltd. | Insulin Syringe
Device Classification Name: syringe, piston
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233794

Deerfield Imaging, Inc. | InVision™ 1.5 Surgical Theatre
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240157

Gelb Practice Solutions, Inc. | airVata™
Device Classification Name: device, anti-snoring
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240427

Deerfield Imaging, Inc. | InVision™ 1.5 Surgical Theatre
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240157

TriSalus Life Sciences | TriSalus TriGuideTM Guiding Catheter
Device Classification Name: catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233858

3M Unitek Orthodontic Products | 3M™ Transbond™ Orthodontic Adhesive
Device Classification Name: adhesive, bracket and tooth conditioner, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234043

Siemens Healthcare GmbH | syngo Virtual Cockpit (VB10A)
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232744

Acutus Medical, Inc. | FlexCath Cross Transseptal Solution
Device Classification Name: introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233691

BB Imaging | TeleScan
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233634

FUJIFILM SonoSite Inc. | Sonosite LX Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233597

Philips Ultrasound LLC | EPIQ Series Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233545

Micro Current Technology, Inc. | MF SC Facial Toning System
Device Classification Name: stimulator, transcutaneous electrical, aesthetic purposes
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233525

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | VarseoSmile TriniQ
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233596

Guangzhou Easycess Medical Co., Ltd | Easycess Aspiration Pump
Device Classification Name: apparatus, suction, ward use, portable, ac-powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233428

Handpiece Headquarters | BASE290 LED Curing Light
Device Classification Name: activator, ultraviolet, for polymerization
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233518

GuideStar Medical Devices | EpiZact
Device Classification Name: syringe, piston
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233056

Pollogen Ltd | Legend X Platform
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232903

Cross Vascular Inc. | Cross Vascular RF Generator and Footswitch (optional accessory)
Device Classification Name: electrosurgical, cutting & coagulation & accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232809

Cross Vascular Inc. | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Device Classification Name: catheter, septostomy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232852

Synaptive Medical Inc. | Synq Software Version 1.3
Device Classification Name: system, nuclear magnetic resonance imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232981

Invivo Corporation (Business Trade Name: Philips) | dS Breast Coil 7ch 1.5T
Device Classification Name: coil, magnetic resonance, specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232762

3M Company, Unitek Orthodontic Products | 3M™ Clarity™Aligners with Quick Attachments
Device Classification Name: aligner, sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233257

Shofu Dental Corporation | BeautiLink SA
Device Classification Name: cement, dental
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233161

Siemens Medical Solutions, USA, Inc | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232617

Sino-Dentex Co., Ltd. | DX. Bond V Dental Bonding Adhesive
Device Classification Name: agent, tooth bonding, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232978

Passy-Muir, Inc. | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Device Classification Name: filter, bacterial, breathing-circuit
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230483

LightForce Orthodontics | LightForce Orthodontic System
Device Classification Name: bracket, ceramic, orthodontic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232827

Zirkonzahn Srl | Polibond
Device Classification Name: resin, denture, relining, repairing, rebasing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232691

Sleepiz AG | Sleepiz One+
Device Classification Name: monitor, cardiac (incl. cardiotachometer & rate alarm)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223163

Altris, Inc. | Altris IMS
Device Classification Name: system, image management, ophthalmic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232088

US Glove Supply | MemorialTM Gloves
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231740

Bemer INT AG | Bemer Therapy System Evo
Device Classification Name: stimulator, muscle, powered, for muscle conditioning
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231368

DICOM Grid dba Ambra Health | Ambra PACS
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231360

3M Company, Unitek Orthodontic Products | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
Device Classification Name: aligner, sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231464

Mectron S.p.A. | Combi Touch
Device Classification Name: scaler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231391

Philips Ultrasound LLC | EPIQ Series Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231190

3M ESPE Dental Products | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Device Classification Name: varnish, cavity
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231338

TriSalus Life Sciences | TriSalus TriNav® LV Infusion System
Device Classification Name: catheter, continuous flush
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230957

Chongqing Rob Linka Science And Technology Co., Ltd. | TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230829

Alliage S/A Industrias Medica Odontológico. | Eagle S/Saevo Slim/D700 Slim
Device Classification Name: system, x-ray, extraoral source, digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230732

Sprig Oral Health Technologies, Inc. | SmartMTA Capsule
Device Classification Name: resin, root canal filling
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230797

CyMedica Orthopedics, Inc. | Motive™ Electrode
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230533

Siemens Healthcare GmBH | Syngo Carbon Space VA30A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230561

ALG Health LLC | Savvy Surgical Mask – Level 3
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230383

Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230207

Siemens Healthcare GmBH | syngo.via View&GO VA40A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230196

SEND EMAIL
[email protected]
CALL US NOW
+1 763 682 4139
FIND US HERE
Saint Paul, MN, USA
Resize text-+=