Product code BWC
- Device name
- Needle, Emergency Airway
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5090
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200190 | ScalpelCric | VBM Medizintechnik GmbH | 2020-10-30 |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | Cook Incorporated | 2017-02-17 |
| K153761 | Emergency Transtracheal Airway Catheter | Cook Incorporated | 2016-09-22 |
| K130405 | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | Teleflex Medical | 2013-11-06 |
| K050166 | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | Smiths Medical | 2005-05-26 |
| K013241 | ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2002-02-21 |
| K013252 | PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2002-02-21 |
| K013916 | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2001-12-20 |
| K010016 | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER | Cook, Inc. | 2001-10-09 |
| K962312 | KEY CHAIN EMERGENCY AIRWAY | Ffrench Pocket Emergency Airway, Inc. | 1997-06-17 |
| K952401 | ABELSON CRICOTHYROTOMY CANNULA | Gilbert Surgical Instruments, Inc. | 1995-07-11 |
| K853345 | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE | 31st. Centruy Medical Corp. | 1985-10-01 |
| K790650 | WEISS EMERGENCY AIRWAY SYSTEM | Intl. Medical Devices , Ltd. | 1979-06-27 |
| K771587 | INSTANT AIR | Hyde, Vernon E., D.D.S. | 1977-09-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250105630770 | ScalpelCric | VBM Medizintechnik GmbH | 2026-05-08 |
| 04250105629736 | ScalpelCric | VBM Medizintechnik GmbH | 2022-12-21 |
| 04250105628111 | n.a. | VBM Medizintechnik GmbH | 2020-11-09 |
| 14250105628118 | n.a. | VBM Medizintechnik GmbH | 2020-11-09 |
| 15019315110528 | Portex | ICU MEDICAL, INC. | 2017-05-29 |
| 35019315110522 | Portex | ICU MEDICAL, INC. | 2017-05-29 |
| 00827002077966 | Patil | COOK INCORPORATED | 2015-10-24 |
| 00827002082519 | Arndt | COOK INCORPORATED | 2015-10-24 |
| 00827002089501 | Patil | COOK INCORPORATED | 2015-10-24 |
| 00827002094130 | Cook | COOK INCORPORATED | 2015-10-24 |
| 00827002103382 | Cook | COOK INCORPORATED | 2015-10-24 |
| 04026704111671 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 15019315010989 | Portex | ICU MEDICAL, INC. | 2015-09-01 |