FDA Product Code
FDA Product Code ODB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183171 | ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC | 2019-10-08 | Traditional | PDF ↗ |
| K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016-04-19 | Traditional | PDF ↗ |
| K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | Minos Medical | 2008-06-10 | Traditional | PDF ↗ |
| K060475 | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 | Olympus Medical Systems Corporation | 2006-03-17 | Special | PDF ↗ |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | Karl Storz Endoskop GmbH | 1994-09-14 | Traditional | PDF ↗ |
Product code ODB · Class II · Gastroenterology, Urology. Data: openFDA.