Endoscopic Contamination Prevention Sheath
The Endoscopic Contamination Prevention Sheath (product code ODB) is a gastroenterology and urology device that provides a protective barrier between the patient's body and the endoscope, preventing contamination of the endoscope and reducing infection risk during procedures. The sheath is placed over the endoscope prior to insertion. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODB
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183171 | ScopeSeal Duodenoscope Protective Device | Oct 08, 2019 | Substantially Equivalent | Gi Scientific, LLC |
| K153698 | LumenR Tissue Retractor System | Apr 19, 2016 | Substantially Equivalent | Lumenr, LLC |
| K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | Jun 10, 2008 | Substantially Equivalent | Minos Medical |
| K060475 | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 | Mar 17, 2006 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Sep 14, 1994 | Substantially Equivalent | Karl Storz Endoskop GmbH |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.