K944795 is an FDA 510(k) clearance for the KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES. This device is classified as a Electrode, Electrosurgical, Active, Urological (Class II - Special Controls, product code FAS).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 21, 1994, 84 days after receiving the submission on September 28, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K944795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1994 |
| Decision Date | December 21, 1994 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAS — Electrode, Electrosurgical, Active, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |