K993604 is an FDA 510(k) clearance for the ENDOSCOPIC ANTI FOG DEVICE, a Anti Fog Solution And Accessories, Endoscopy (Class II — Special Controls, product code OCT), submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on March 3, 2000, 130 days after receiving the submission on October 25, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K993604 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 1999 |
| Decision Date | March 03, 2000 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | OCT — Anti Fog Solution And Accessories, Endoscopy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens. |