510(k) K083471 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
| Applicant | Generic Medical Device, Inc., Gig Harbor WA, US |
| Decision | Substantially Equivalent, Mar 3, 2009 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2011 | Generic Medical Devices The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only.
The GMD Universal Sling is a sterile, single use device for the treatment of Terminated |
FTL | None listed |
| Nov 16, 2009 | Generic Medical Devices GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18.
Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethra Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.