K042285 is an FDA 510(k) clearance for the UNICRYL M, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by United Medical Industries Co. , Ltd. (Riyadh, Central Province, SA). The FDA issued a Cleared decision on December 10, 2004, 108 days after receiving the submission on August 24, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K042285 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2004 |
| Decision Date | December 10, 2004 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4840 |