Panels › Gastroenterology, Urology › Product code ODB · Class 2
Endoscopic Contamination Prevention Sheath
Regulation 876.1500
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ODB
| Company | 510(k)s | Recalls |
|---|---|---|
| Gi Scientific, LLC | 1 | 0 |
| Karl Storz Endoskop GmbH | 1 | 0 |
| Lumenr, LLC | 1 | 0 |
| Minos Medical | 1 | 0 |
| Olympus Medical Systems Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2019 | K183171 | ScopeSeal Duodenoscope Protective Device Gi Scientific, LLC | ODB |
| Apr 19, 2016 | K153698 | LumenR Tissue Retractor System Lumenr, LLC | ODB |
| Jun 10, 2008 | K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 Minos Medical | ODB |
| Mar 17, 2006 | K060475 | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 Olympus Medical Systems Corporation | ODB |
| Sep 14, 1994 | K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS Karl Storz Endoskop GmbH | ODB |
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