K211307 is an FDA 510(k) clearance for the GalaSTITCH Absorbable Monofilament 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 May 27, 2021, 28 days after receiving the submission on April 29, 2021.
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 | K211307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2021 |
| Decision Date | May 27, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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. |