K120284 is an FDA 510(k) clearance for the DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on May 23, 2012, 113 days after receiving the submission on January 31, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K120284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2012 |
| Decision Date | May 23, 2012 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| 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 |