K123940 is an FDA 510(k) clearance for the DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Demetech Corp. (Apollo Beach, US). The FDA issued a Cleared decision on May 30, 2014, 526 days after receiving the submission on December 20, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K123940 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2012 |
| Decision Date | May 30, 2014 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4493 |