K963015 is an FDA 510(k) clearance for the SURGICAL STAPLE MARKER DEVICE (MODIFY). This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Biopsys Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 7, 1996, 74 days after receiving the submission on July 25, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K963015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1996 |
| Decision Date | October 07, 1996 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |