K082178 is an FDA 510(k) clearance for the TEPHAFLEX ABSORBABLE SUTURE. This device is classified as a Suture, Recombinant Technology (Class II - Special Controls, product code NWJ).
Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on October 30, 2008, 90 days after receiving the submission on August 1, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4494. Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation..
| 510(k) Number | K082178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2008 |
| Decision Date | October 30, 2008 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NWJ - Suture, Recombinant Technology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4494 |
| Definition | Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation. |