Submission Details
| 510(k) Number | K011793 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
KSEA FIBERSCOPE
Apr 2002
Decision
313d
Days
Class 2
Risk
About This 510(k) Submission
K011793 is an FDA 510(k) clearance for the KSEA FIBERSCOPE, 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 review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | LYK — Angioscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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