FDA clears 27 GI devices in 2015 thus far

Here are 27 GI/endoscopy devices that received FDA 510(k) clearance from January to July of this year.  

1.    FilmArray Gastrointestinal Panel for use with FilmArray 2.0 from BioFire Diagnostics.

2.    Coldplay Full Cryoballoon Ablation System and Coldplay Swipe Cryoballoon Ablation System from C2 Therapeutics.

3.    GastriSail Gastric Positioning System from Covidien.

4.    Barrx Anorectal RFA Wand from Covidien.

5.    Disposable Endoscopic Cannula from Dongguan Microview Medical Technology.

6.    EndoChoice Water Bottle Cap System from EndoChoice.

7.    EsophyX Z Fastener Delivery Device from EndoGastric Solutions.

8.    EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes from FUJIFILM Medical Systems.

9.    FUJIFILM Endoscope Models EC-600HL and EC-600LS from FUJIFILM Medical Systems.

10.    MiroCam Capsule Endoscopy System from Intromedic.

11.    Endoscope Sterilization Tray from Intuitive Surgical.

12.    Lagis Endoscopic Instruments Disposable Grasper from Lagis Enterprises.

13.    MUSE System from Medigus.

14.    Bulldog Biopsy Valve, Olympus, Fujinon and Pentax compatible, disposable form Medovations.

15.    Polypectomy snare from Micro-Tech.

16.    FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator from Minimally Invasive Devices.

17.    LiverMultiScan from Mirada Medical.

18.    Endocapsule Software 10; Endocapsule Software 10 Light from Olympus Medical Systems.

19.    Single Use Preloaded Sphincterotome from Olympus Medical Systems.

20.    AqaNife from Ovesco Endoscopy.

21.    IMMULITE IGF Control Module, IMMULITE Gastrin Control Module from Siemens Healthcare Diagnostics.

22.    Ensizor Endoscopic Scissors from Slater Endoscopy.

23.    ProCinch Adjustable Loop Device from Stryker Endoscopy.

24.    Lariat snare from United States Endoscopy Group.

25.    Infinity ERCP sampling device from United States Endoscopy Group.  

26.    Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets from Xeridiem.

27.    Bi-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube from Xeridiem.

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers

Featured Podcast