Applicator (Laryngo-Tracheal), Topical Anesthesia
The Laryngo-Tracheal Topical Anesthesia Applicator is an anesthesiology device designed to deliver topical anesthetic agents directly to the laryngeal and tracheal surfaces, reducing patient discomfort and suppressing airway reflexes prior to or during instrumentation of the airway. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCT, regulated under 21 CFR 868.5170, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CCT
- Device Class
- FDA class 2
- Regulation Number
- 868.5170
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | Oct 16, 2024 | Substantially Equivalent | Dualams, Inc., Dba Airkor |
| K172956 | Medicant Mucosal Atomizer | Apr 06, 2018 | Substantially Equivalent | Medica Holdings, LLC |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Aug 19, 2016 | Substantially Equivalent | Teleflex Medical |
| K093584 | EZ-MISTER | Mar 04, 2011 | Substantially Equivalent | N.M. Beale Co., Inc. |
| K070596 | TOPICAL APPLICATOR | Jun 21, 2007 | Substantially Equivalent | Sharn, Inc. |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Sep 18, 2000 | Substantially Equivalent | Wolfe Tory Medical, Inc. |
| K894755 | ASTRA DISPOSABLE SPRAY CANNULA | Jan 12, 1990 | Substantially Equivalent | Astra Pharmaceutical Products, Inc. |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | Feb 26, 1981 | Substantially Equivalent | Ackrad Laboratories |
| K760877 | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT | Dec 09, 1976 | Substantially Equivalent | Sherwood Medical Industries |
| K760759 | ANESTHESIA KIT | Dec 09, 1976 | Substantially Equivalent | Sherwood Medical Industries |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.