K093616 is an FDA 510(k) clearance for the V. MUELLER CAMERA CONTROLLER WITH STORAGE CART, a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by Carefusion 2200 (Waukegan, US). The FDA issued a Cleared decision on December 23, 2009, 34 days after receiving the submission on November 19, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K093616 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2009 |
| Decision Date | December 23, 2009 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCV — Endoscope Holder |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Hold Endoscope In A Desired Position During Procedures. |