CCT · Applicator (Laryngo-Tracheal), Topical Anesthesia
Anesthesiology · 21 CFR 868.5170 · Class 2
Overview
| Product Code | CCT |
|---|---|
| Device Name | Applicator (Laryngo-Tracheal), Topical Anesthesia |
| Regulation | 21 CFR 868.5170 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | Oct 16, 2024 | SESE |
| K172956 | Medicant Mucosal Atomizer | Medica Holdings, LLC | Apr 6, 2018 | SESE |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | Aug 19, 2016 | SESE |
| K093584 | EZ-MISTER | N.M. Beale Co., Inc. | Mar 4, 2011 | SESE |
| K070596 | TOPICAL APPLICATOR | Sharn, Inc. | Jun 21, 2007 | SESE |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Wolfe Tory Medical, Inc. | Sep 18, 2000 | SESE |
| K894755 | ASTRA DISPOSABLE SPRAY CANNULA | Astra Pharmaceutical Products, Inc. | Jan 12, 1990 | SESE |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | Ackrad Laboratories | Feb 26, 1981 | SESE |
| K760877 | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT | Sherwood Medical Industries | Dec 9, 1976 | SESE |
| K760759 | ANESTHESIA KIT | Sherwood Medical Industries | Dec 9, 1976 | SESE |
Top Applicants
- Sherwood Medical Industries — 2 clearances
- Ackrad Laboratories — 1 clearance
- Astra Pharmaceutical Products, Inc. — 1 clearance
- Dualams, Inc., Dba Airkor — 1 clearance
- Medica Holdings, LLC — 1 clearance
