K051281 is an FDA 510(k) clearance for the THE NEEDLE CATCHER, a Forceps (Class I — General Controls, product code HTD), submitted by E.D.Medical , Ltd. (Belfast, GB). The FDA issued a Cleared decision on September 8, 2005, 114 days after receiving the submission on May 17, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K051281 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 2005 |
| Decision Date | September 08, 2005 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HTD — Forceps |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |