ODB · Class II · 21 CFR 876.1500

FDA Product Code ODB: Endoscopic Contamination Prevention Sheath

To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope.

Leading manufacturers include Karl Storz Endoskop GmbH, Olympus Medical Systems Corporation and Minos Medical.

5
Total
5
Cleared
123d
Avg days
1994
Since

FDA 510(k) Cleared Endoscopic Contamination Prevention Sheath Devices (Product Code ODB)

5 devices
1–5 of 5
Cleared Oct 08, 2019
ScopeSeal Duodenoscope Protective Device
K183171
Gi Scientific, LLC
Gastroenterology & Urology · 326d
Cleared Apr 19, 2016
LumenR Tissue Retractor System
K153698
Lumenr, LLC
Gastroenterology & Urology · 118d
Cleared Jun 10, 2008
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
K080550
Minos Medical
Gastroenterology & Urology · 103d
Cleared Mar 17, 2006
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
K060475
Olympus Medical Systems Corporation
Radiology · 22d
Cleared Sep 14, 1994
TROCARS,CANNULAE,SHEATHS,OBTURATORS
K943697
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 47d

About Product Code ODB - Regulatory Context