OCV — Endoscope Holder Class II
FDA product code OCV covers "Endoscope Holder", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCV
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To hold endoscope in a desired position during procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240506 | karl storz endoscopy america | KARL STORZ Holders | October 22, 2024 |
| K232405 | aktormed | ENDOFIX EXO | April 25, 2024 |
| K190576 | biomet microfixation | WalterLorenz Surgical Assist Arm Scope Holder | June 5, 2019 |
| K102179 | carefusion 2200 | ENVIEW (TM) | December 2, 2010 |
| K093616 | carefusion 2200 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | December 23, 2009 |
| K992006 | integra neurocare | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | August 17, 1999 |
| K990334 | karl storz endoscopy-america | KSEA ENDOSCOPE HOLDER | March 22, 1999 |
| K971584 | clarus medical systems | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | May 23, 1997 |
| K960068 | olympus america | SH-1 SURGICAL HOLDER FOR TELESCOPE | May 5, 1997 |
| K810787 | urology group | UROLOGIC TUBE HOLDER | March 31, 1981 |