K970817 is an FDA 510(k) clearance for the MICROMARK CLIP. 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 September 11, 1997, 189 days after receiving the submission on March 6, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K970817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1997 |
| Decision Date | September 11, 1997 |
| Days to Decision | 189 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 |