ODB — Endoscopic Contamination Prevention Sheath Class II
FDA product code ODB covers "Endoscopic Contamination Prevention Sheath", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODB
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183171 | Gi Scientific | ScopeSeal Duodenoscope Protective Device | Oct 8, 2019 |
| K153698 | Lumenr | LumenR Tissue Retractor System | Apr 19, 2016 |
| K080550 | Minos Medical | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | Jun 10, 2008 |
| K060475 | Olympus Medical Systems Corporation | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 | Mar 17, 2006 |
| K943697 | Karl Storz Endoskop | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Sep 14, 1994 |