26 GI/Endoscopy Devices Receive FDA 510(k) Clearance in 2014

Here are 26 GI/endoscopy-related devices that received FDA 510(k) clearance thus far in 2014.

1.    FilmArray Gastrointestinal Panel from Biofire Diagnostics.

2.    Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers from Boston Scientific.

3.    Captivator II, Single-Use Polypectomy Snares from Boston Scientific.

4.    Expect Slimline Endoscopic Ultrasound Aspiration Needle from Boston Scientific.

5.    Wallflex Biliary Rx Stent System from Boston Scientific.

6.    PROTOCO2 L Touch Colon Insufflator from Bracco Diagnostics.

7.    ENDO GIA Extra Long Adapter from Covidien.

8.    ENDO GIA Reinforced Reload with Tri-Staple Technology from Covidien.

9.    EndoRings from EndoAid.

10.    EndoChoice Water Bottle Cap Irrigation System from EndoChoice.

11.    Fuse 1C Colonoscopy System from EndoChoice.

12.    Injection Needle from EndoChoice.

13.    Seal Single-Use Biopsy Valve from EndoChoice.

14.    Optiflux Ultra Dialyzer from Fresenius Medical Care.

15.    Vscan with Dual Probe from GE Medical Systems Ultrasound.

16.    FUJIFILM 600 Series Endoscopes from FUJIFILM Medical Systems.

17.    SRS Endoscopic Stapling System from Medigus.

18.    Endoscope Position Marking Probe, Endoscope Position Detecting Unit from Olympus Medical Systems.

19.    THUNDERBEAT from Olympus Medical Systems.

20.    Pentax Video Colonoscopes from Pentax Medical Company.

21.    Pentax Video Upper GI Scopes from Pentax Medical Company.

22.    Anal Rectal Overtube from United States Endoscopy Group.

23.    Endoscopic Suture Cutter from United States Endoscopy Group.

24.    Monofilament Polypectomy Snare from United States Endoscopy Group.

25.    Torrent Irrigation System from United States Endoscopy Group.

26.    US Endoscopy Distal Attachment Cap from United States Endoscopy Group.

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How Will Bundled Payments Affect GI? 3 Gastroenterologists Chime In
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