K030227 is an FDA 510(k) clearance for the SUTURTEK FASTCLOSE SUTURING DEVICE, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Suturtek Incorporated (Hopkonton, US). The FDA issued a Cleared decision on March 17, 2003, 54 days after receiving the submission on January 22, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K030227 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 2003 |
| Decision Date | March 17, 2003 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |