K011793 is an FDA 510(k) clearance for the KSEA FIBERSCOPE. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 17, 2002, 313 days after receiving the submission on June 8, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K011793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2001 |
| Decision Date | April 17, 2002 |
| Days to Decision | 313 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 |