K810324 is an FDA 510(k) clearance for the AUTOMATIC HEMOCLIP APPLIER, 527700. This device is classified as a Staple, Implantable (Class II — Special Controls, product code GDW).
Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981, 42 days after receiving the submission on February 6, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K810324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1981 |
| Decision Date | March 20, 1981 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4750 |