K991223 is an FDA 510(k) clearance for the ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC. This device is classified as a Suture, Absorbable, Natural (Class II - Special Controls, product code GAL).
Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on April 30, 1999, 18 days after receiving the submission on April 12, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K991223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1999 |
| Decision Date | April 30, 1999 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |