510(k) K910914 ยท KGY Bag, Intestine
SURGICAL TISSUE POUCH
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Mar 28, 1991 |
| Received | Mar 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2015 | Cook Inc. LapSac Surgical Tissue Pouch.
The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinfor Terminated |
KGY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.