510(k) K082536 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
COOK WIRE GUIDES
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Oct 27, 2008 |
| Received | Sep 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire
Reference Part Number/GPN:
RPC-035145-0-5 G34131
RPC-035145 G18154
RPC-035145-5 G34132
RPC-038145-0-5 G34129
RFSPC-038145-0 G17539
RFSPC-035 Open, Classified |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 Terminated |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 Terminated |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323
G14260
G14260 Terminated |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. PTFE Wire Guide, Guidewire, Global Product Number 638813
635413-10 Terminated |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866 Terminated |
OCY | None listed |
| Jan 4, 2019 | Cook Inc. Wire Guide, Guidewire, Global Product Number G14326 Terminated |
OCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.