510(k) K120284 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | Jan 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Coloplast Manufacturing US, LLC Digitex Absorbable Polydiaxanone Suture, Size 2-0.
Catalog Number / Code of product: 52031, 5203101400.
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to th Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.