510(k) K010016 ยท BWC Needle, Emergency Airway
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 9, 2001 |
| Received | Jan 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193;
Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. Open, Classified |
BWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.