K944110 is an FDA 510(k) clearance for the VICRYL RAPIDE SUTURE. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 18, 1995, 148 days after receiving the submission on August 23, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K944110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 23, 1994 |
| Decision Date | January 18, 1995 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4493 |