OCS — Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II
FDA product code OCS covers "Endoscopic Video Imaging System/Component, Gastroenterology-Urology", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OCS
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100852 | stryker communications | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 | May 6, 2010 |