K933216 is an FDA 510(k) clearance for the KARL STORZ ENDOSCOPY-AMERICA, INC.. This device is classified as a Image, Illumination, Fiberoptic, For Endoscope (Class II - Special Controls, product code FFS).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 9, 1993, 135 days after receiving the submission on April 27, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K933216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1993 |
| Decision Date | September 09, 1993 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |