K060828 is an FDA 510(k) clearance for the MODIFICATION TO ENDOTINE RIBBON. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Coapt Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 19, 2006, 23 days after receiving the submission on March 27, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K060828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2006 |
| Decision Date | April 19, 2006 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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 |