K040109 is an FDA 510(k) clearance for the HEMORRHAGE OCCLUDER PIN, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Tools For Surgery, LLC (Stony Brook, US). The FDA issued a Cleared decision on March 25, 2004, 65 days after receiving the submission on January 20, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K040109 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2004 |
| Decision Date | March 25, 2004 |
| Days to Decision | 65 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 |