| Device Type ID | 120 |
| Device Name | Applicator (laryngo-tracheal), Topical Anesthesia |
| Regulation Description | Laryngotracheal Topical Anesthesia Applicator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 120 |
| Device | Applicator (laryngo-tracheal), Topical Anesthesia |
| Product Code | CCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laryngotracheal Topical Anesthesia Applicator. |
| CFR Regulation Number | 868.5170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Crack | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Aug-25-2017 |
| 2 | Teleflex Medical | II | Nov-09-2016 |
| 3 | Teleflex Medical Europe Ltd | II | May-23-2018 |