K011375 is an FDA 510(k) clearance for the AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on June 29, 2001, 56 days after receiving the submission on May 4, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K011375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2001 |
| Decision Date | June 29, 2001 |
| Days to Decision | 56 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 |