K030031 is an FDA 510(k) clearance for the SOFT TISSUE ANCHORING WASHERS, a Retention Device, Suture (Class I — General Controls, product code KGS), submitted by Accu-Speed, Incorporated (Groton, US). The FDA issued a Cleared decision on January 28, 2003, 25 days after receiving the submission on January 3, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K030031 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 2003 |
| Decision Date | January 28, 2003 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4930 |