K920978 is an FDA 510(k) clearance for the ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED. This device is classified as a Suture, Absorbable, Synthetic (Class II - Special Controls, product code GAN).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on February 15, 1994, 715 days after receiving the submission on March 2, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K920978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1992 |
| Decision Date | February 15, 1994 |
| Days to Decision | 715 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAN — Suture, Absorbable, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |