FDA clears 51 GI/endoscopy devices in 2015

Here are 51 gastroenterology and endoscopy devices that received FDA 510(k) clearance in 2015.


1.    Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only from Alere San Diego.

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

3.    Arc Endocuff Vision from Boddingtons Plastics.

4.    AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System from Boston Scientific.

5.    Resolution Clip from Boston Scientific.

6.    WALLSTENT RP Endoprosthesis Transhepatic Biliary from Boston Scientific.

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

8.    Peristeen Anal Irrigation System from Coloplast.

9.    Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set from Cook Inc.

10.    Barrx Anorectal RFA Wand from Covidien.

11.    GastriSail Gastric Positioning System from Covidien.

12.    Premium Surgiclip, EndoClip, AcuClip from Covidien.

13.    Disposable Endoscopic Cannula from Dongguan Microview Medical Technology.

14.    EndoChoice Water Bottle Cap System from EndoChoice.

15.    Fuse Gastroscopy System from EndoChoice.

16.    Rescuenet from EndoChoice.

17.    EsophyX Z Fastener Delivery Device from EndoGastric Solutions.

18.    Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier from Ethicon Endo-Surgery.

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

20.    FUJIFILM Double Balloon Endoscopes Models EN-530T and EN-580T from FUJIFILM Medical Systems.

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

22.    MiroCam Capsule Endoscopy System from Intromedic.

23.    Endoscope Sterilization Tray from Intuitive Surgical.

24.    KSEA CMOS Camera System from Karl Storz Endoscopy-America.

25.    SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link from Karl Storz Endoscopy-America.

26.    Lagis Endoscopic Instruments Disposable Grasper from Lagis Enterprises.

27.    MUSE System from Medigus.

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

29.    Polypectomy snare from Micro-Tech.

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

31.    LiverMultiScan from Mirada Medical.

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

33.    Single-Use Aspiration Needle NA-U200H from Olympus Medical Systems.

34.    Single Use Balloon Dilator V with Knife from Olympus Medical Systems.

35.    Single Use Preloaded Sphincterotome from Olympus Medical Systems.

36.    Visera 4K UHD System from Olympus Medical Systems.

37.    OES Elite Telescopes, Protective Tube from Olympus Winter & IBE GMBH.

38.    AqaNife from Ovesco Endoscopy.

39.    Advanced Imaging Modality Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray from Paragon Medical.

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

41.    Ensizor Endoscopic Scissors from Slater Endoscopy.

42.    ProCinch Adjustable Loop Device from Stryker Endoscopy.

43.    Weck Auto Endo5 Hem-o-lok Ligating Clip Applier from Teleflex Medical.

44.    AquaShield system CO2, AquaShield system-PENTAX from United States Endoscopy Group.

45.    BioGuard Air/Water Valve, BioGuard Suction Valve from United States Endoscopy Group.

46.    Lariat snare from United States Endoscopy Group.

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

48.    iSnare system-Lariat from United States Endoscopy Group.

49.    Disposable Endoscope Valves Set AT from Wilson Instruments.

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

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


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