K961460 is an FDA 510(k) clearance for the LWEET CONE BIOPSY INSTRUMENT. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Apple Medical Corp. (Ringoes, US). The FDA issued a Cleared decision on November 19, 1996, 217 days after receiving the submission on April 16, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K961460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1996 |
| Decision Date | November 19, 1996 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGI — Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4120 |