510(k) K093845 ยท GDW Staple, Implantable
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Apr 7, 2010 |
| Received | Dec 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2011 | Ethicon, Inc. Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25.
Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.