Product code CCT
- Device name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5170
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- 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 |
|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| K172956 | Medicant Mucosal Atomizer | Medica Holdings, LLC | 2018-04-06 |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | 2016-08-19 |
| K093584 | EZ-MISTER | N.M. Beale Co., Inc. | 2011-03-04 |
| K070596 | TOPICAL APPLICATOR | Sharn, Inc. | 2007-06-21 |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| K894755 | ASTRA DISPOSABLE SPRAY CANNULA | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | Ackrad Laboratories | 1981-02-26 |
| K760759 | ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 |
| K760877 | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14026704709868 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 14026704709875 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 14026704709882 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 24026704709889 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 24026704709872 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 34026704709862 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 00841470103804 | DART-Reach | ENGINEERED MEDICAL SYSTEMS INC | 2022-03-25 |
| 10841470100336 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 10841470100329 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 10841470100312 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 00841470103828 | DART-Reach | ENGINEERED MEDICAL SYSTEMS INC | 2022-03-25 |
| 00841470103811 | DART-Reach | ENGINEERED MEDICAL SYSTEMS INC | 2022-03-25 |
| 00841470100339 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 00841470100315 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 00841470100322 | DART-Reach | PULMODYNE INC | 2022-03-25 |
| 14026704717535 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2020-07-30 |
| 14026704717542 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2020-07-30 |
| 14026704717559 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2020-07-30 |
| 14026704613219 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-10-27 |
| 14026704613226 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-25 |
| 14026704613196 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-25 |
| 00815277021401 | Curaplex | BOUND TREE MEDICAL, LLC | 2016-12-14 |
| 00815277021517 | Curaplex | BOUND TREE MEDICAL, LLC | 2016-12-14 |
| 00815277027823 | Curaplex | BOUND TREE MEDICAL, LLC | 2016-12-14 |
| 05060112313189 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |
| 05060112313202 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |
| 05060112313226 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |
| 05060112313233 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |
| 05060112313240 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |
| 05060112313172 | LMA | TELEFLEX INCORPORATED | 2016-09-16 |