K944955 is an FDA 510(k) clearance for the AESCULAP THORACOSCOPIC INSTRUMENTS. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on November 9, 1994, 33 days after receiving the submission on October 7, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K944955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1994 |
| Decision Date | November 09, 1994 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |