K100461 is an FDA 510(k) clearance for the PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on July 8, 2010, 140 days after receiving the submission on February 18, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K100461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2010 |
| Decision Date | July 08, 2010 |
| Days to Decision | 140 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |