FDA Product Code
FDA Product Code NWB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222020 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | 2022-09-08 | Traditional | PDF ↗ |
| K211882 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | 2022-04-01 | Traditional | PDF ↗ |
| K173921 | HD-500 Video Endoscope System | Sonoscape Medical Corp. | 2018-09-05 | Traditional | PDF ↗ |
| K133538 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE | Olympus Corporation of the Americas | 2014-08-07 | Traditional | PDF ↗ |
| K100584 | EVIS EXERAII 180 SYSTEM | Olympus Medical Systems Corporation | 2010-07-02 | Traditional | PDF ↗ |
| K090980 | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | Olympus Winter & Ibe GmbH | 2009-06-29 | Traditional | PDF ↗ |
| K072957 | EVIS EXERA II 180 SYSTEM | Olympus Medical Systems Corporation | 2008-03-18 | Traditional | PDF ↗ |
| K062049 | EVIS EXERA II 180 SYSTEM | Olympus Medical Systems Corporation | 2006-09-22 | Traditional | PDF ↗ |
| K051645 | EVIS EXERA 160A SYSTEM | Olympus Medical Systems Corporation | 2005-10-13 | Traditional | PDF ↗ |
Product code NWB · Class II · Gastroenterology, Urology. Data: openFDA.