K012724 is an FDA 510(k) clearance for the SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 8, 2001, 86 days after receiving the submission on August 14, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K012724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2001 |
| Decision Date | November 08, 2001 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |