K946359 is an FDA 510(k) clearance for the KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on May 11, 1995, 132 days after receiving the submission on December 30, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K946359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1994 |
| Decision Date | May 11, 1995 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |