56 GI devices receive FDA 510(k) clearance in 2014

Innovation in healthcare may face regulatory and funding hurdles, but new gastroenterology and endoscopy technology continues to enter the market. Here are 56 GI/endoscopy devices that received U. S. Food and Drug Administration 510(k) clearance in 2014.

1. Third Eye Panoramic Auxiliary Endoscopy System from Avantis Medical Systems.

2. FilmArray Gastrointestinal Panel from Biofire Diagnostics.

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

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

5. Captivator EMR Device for Standard Gastroscopes from Boston Scientific.

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

7. Wallflex Biliary Rx Stent System from Boston Scientific.

8. PROTOCO2 L Touch Colon Insufflator from Bracco Diagnostics.
 
9. Consure Stool Management System from Consure Medical.

10. ENDO GIA Extra Long Adapter from Covidien.

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

12. Sharkcore Fine Needle Biopsy System from Covidien.

13. Flex Endoscopic Instruments from Design Standards Corp.

14. ERB Endorectal Balloon from Edge Medical.

15. EndoRings from EndoAid.

16. Bonastent Biliary from EndoChoice.

17. Bonastent Tracheal/Bronchial from EndoChoice.

18. EndoChoice Water Bottle Cap Irrigation System from EndoChoice.

19. Fuse 1C Colonoscopy System from EndoChoice.

20. Fuse Colonoscopy System from EndoChoice.  

21. Injection Needle from EndoChoice.

22. Seal Single-Use Biopsy Valve from EndoChoice.

23. EsophyX2 from EndoGastric Solutions.

24. Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector from ERBE USA.

25. Optiflux Ultra Dialyzer from Fresenius Medical Care.

26. FUJIFILM 600 Series Endoscopes from FUJIFILM Medical Systems.

27. EPX-440HD Digital Video Processor from FUJIFILM Medical Systems.

28. FUJIFILM Endoscopic CO2 Regulator from FUJIFILM Medical Systems.

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

30. Given Pillcam UGI Capsule Endoscopy System from Given Imaging.

31. AER-O-Scope Colonoscope System from GI View.

32. MicroCam Capsule Endoscopy System from IntroMedic.

33. Endoscope sterilization tray from Intuitive Surgical.

34. 12mm Endoscopes and Accessories from Intuitive Surgical.

35. Flexible Video-Uretero-Renoscope System from Karl Storz Endoscopy-America.

36. xTag Gastrointestinal Pathogen Panel from Luminex Molecular Diagnostics.

37. xTag Gastrointestinal Pathogen Panel/xTag Data Analysis Software from Luminex Molecular Diagnostics.

38. SRS Endoscopic Stapling System from Medigus.

39. Endo Smart Bottle, Rinse and Insufflation System from Medivators.

40. MINNCARE HD from Medivators.

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

42. EndoLED from Olympus.

43. THUNDERBEAT from Olympus Medical Systems.

44. Traction Polypectomy Snare from Ovesco Endoscopy.

45. Endo-Maryland Dissector from Ovesco Endoscopy.

46. Colonglide lubricant from Pediatric Pharmaceuticals.

47. Pentax Video Colonoscopes from Pentax Medical Company.

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

49. Syngo CT Colonography from Siemens Medical Solutions.

50. IG_Plex Celiac DGP Panel from SQI Diagnostics Systems.

51. Esophageal Stethoscope with Temperature Sensor (Non-Sterile), Esophageal Stethoscope Temperature with Attached Ear Piece from Starboard Medical.

52. Anal Rectal Overtube from United States Endoscopy Group.

53. Endoscopic Suture Cutter from United States Endoscopy Group.

54. Monofilament Polypectomy Snare from United States Endoscopy Group.

55. Torrent Irrigation System from United States Endoscopy Group.

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

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