K992006 is an FDA 510(k) clearance for the NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33, a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by Integra Neurocare, LLC (San Diego, US). The FDA issued a Cleared decision on August 17, 1999, 63 days after receiving the submission on June 15, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K992006 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 1999 |
| Decision Date | August 17, 1999 |
| Days to Decision | 63 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. |