K934724 is an FDA 510(k) clearance for the AESCULAP TROCAR INSTRUMENT SET. This device is classified as a Trocar, Gastro-urology (Class II - Special Controls, product code FBQ).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 23, 1993, 83 days after receiving the submission on October 1, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K934724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1993 |
| Decision Date | December 23, 1993 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FBQ — Trocar, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |