K102179 is an FDA 510(k) clearance for the ENVIEW (TM), a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by Carefusion 2200 (San Diego, US). The FDA issued a Cleared decision on December 2, 2010, 121 days after receiving the submission on August 3, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K102179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 2010 |
| Decision Date | December 02, 2010 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| 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. |