MADgic Laryngo-Tracheal Mucosal Atomization Device
FDA 510(k) clearance K153470 · decided 2016-08-19
Clearance details
- K-number
- K153470
- Device name
- MADgic Laryngo-Tracheal Mucosal Atomization Device
- Applicant
- Teleflex Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-12-02
- Decision date
- 2016-08-19
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- CCT
- Device class
- 2
- Regulation number
- 868.5170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| UltraEzAir® (UEA1A) (K240114) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| Medicant Mucosal Atomizer (K172956) | Medica Holdings, LLC | 2018-04-06 |
| EZ-MISTER (K093584) | N.M. Beale Co., Inc. | 2011-03-04 |
| TOPICAL APPLICATOR (K070596) | Sharn, Inc. | 2007-06-21 |
| LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (K002255) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| ASTRA DISPOSABLE SPRAY CANNULA (K894755) | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| ENDO-MED TUBE FOR ENDOTRACHEAL MED (K810059) | Ackrad Laboratories | 1981-02-26 |
| ANESTHESIA KIT (K760759) | Sherwood Medical Industries | 1976-12-09 |
| MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (K760877) | Sherwood Medical Industries | 1976-12-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MA recall (Z-3212-2017) | Teleflex Medical | 2017-08-25 |
| FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anes recall (Z-0383-2017) | Teleflex Medical | 2016-11-09 |
| LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products ar recall (Z-0384-2017) | Teleflex Medical | 2016-11-09 |