510(k) K841362 ยท GBX Catheter, Irrigation
TIDAL DISTENSION IRRIGATION SET
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 2, 1984 |
| Received | Apr 2, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2014 | Hospira Inc. LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira
Prod Terminated |
GBX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.