K943053 is an FDA 510(k) clearance for the KSEA SEMM TISSUR PUNCH. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Karl Storz Endoskop GmbH (Culver City, US). The FDA issued a Cleared decision on March 21, 1995, 267 days after receiving the submission on June 27, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K943053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1994 |
| Decision Date | March 21, 1995 |
| Days to Decision | 267 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 |