K921405 is an FDA 510(k) clearance for the DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP. This device is classified as a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II - Special Controls, product code HFG).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 25, 1994, 731 days after receiving the submission on March 24, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K921405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1992 |
| Decision Date | March 25, 1994 |
| Days to Decision | 731 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFG — Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4160 |