K931478 is an FDA 510(k) clearance for the ZEISS OPMI L STEREO-LAPAROSCOPE, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Carl Zeiss, Inc. (Princeton, US). The FDA issued a Cleared decision on September 28, 1994, 553 days after receiving the submission on March 24, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K931478 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 24, 1993 |
| Decision Date | September 28, 1994 |
| Days to Decision | 553 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |