Panels › Anesthesiology › Product code BWC · Class 2
Needle, Emergency Airway
Regulation 868.5090
0510(k)s in 12 months (14 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in BWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 6 | 1 |
| 31st. Centruy Medical Corp. | 1 | 0 |
| Ffrench Pocket Emergency Airway, Inc. | 1 | 0 |
| Gilbert Surgical Instruments, Inc. | 1 | 0 |
| Hyde, Vernon E., D.D.S. | 1 | 0 |
| Intl. Medical Devices , Ltd. | 1 | 0 |
| Smiths Medical | 1 | 0 |
| Teleflex Medical | 1 | 0 |
| Tytek Medical Inc | 0 | 1 |
| VBM Medizintechnik GmbH | 1 | 0 |
| 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 | K010016 K160200 |
| Feb 12, 2020 | Tytek Medical Inc PneumoDart, 14 ga x 3.25in., REF TM-317
A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumo Terminated |
BWC | None listed |
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