ODB
5 FDA 510(k) clearances · Product code
103 daysmedian time to decision
326 days90th percentile
5clearances measured
FDA profile
- Official device name
- Endoscopic Contamination Prevention Sheath
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ScopeSeal Duodenoscope Protective Device (K183171) | Gi Scientific, LLC | 2019-10-08 |
| LumenR Tissue Retractor System (K153698) | Lumenr, LLC | 2016-04-19 |
| MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (K080550) | Minos Medical | 2008-06-10 |
| EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 (K060475) | Olympus Medical Systems Corporation | 2006-03-17 |
| TROCARS,CANNULAE,SHEATHS,OBTURATORS (K943697) | Karl Storz Endoskop GmbH | 1994-09-14 |
Track ODB automatically
Every clearance here is in the API, with alerts when new ones post.