K911915 is an FDA 510(k) clearance for the HEMOCLIP II. This device is classified as a Clip, Implantable (Class II — Special Controls, product code FZP).
Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on January 9, 1992, 254 days after receiving the submission on April 30, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K911915 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 1991 |
| Decision Date | January 09, 1992 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |