510(k) K160200 ยท BWC Needle, Emergency Airway
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Feb 17, 2017 |
| Received | Jan 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160200
| 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.