OCVClass II
Endoscope Holder
21 CFR 876.1500 / Gastroenterology, Urology
OCV is the FDA product code for Endoscope Holder, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To hold endoscope in a desired position during procedures". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OCV
- Device name
- Endoscope Holder
- FDA definition
- To hold endoscope in a desired position during procedures.
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 10
- Ingested recalls
- 0
Clearances, product code OCV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1997 | 2 |
| 1999 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2019 | 1 |
| 2024 | 2 |
Applicants with the most clearances
Product code OCV| Applicant | Clearances |
|---|---|
| Medtronic, Inc. | 2 |
| Karl Storz Endoscopy-America, Inc. | 2 |
| AKTORmed GmbH | 1 |
| Biomet Microfixation | 1 |
| Clarus Medical Systems, Inc. | 1 |
| Integra Neurocare, LLC | 1 |
| OLYMPUS Corporation of the Americas | 1 |
| The Urology Group | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
