| Device Type ID | 4302 |
| Device Name | Unit, Cautery, Thermal, Ac-powered |
| Regulation Description | Thermal Cautery Unit. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4115 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HQO |
| 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 | 4302 |
| Device | Unit, Cautery, Thermal, Ac-powered |
| Product Code | HQO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal Cautery Unit. |
| CFR Regulation Number | 886.4115 [🔎] |
| Device Problems | |
|---|---|
Power Supply | 35 |
Failure To Deliver Energy | 23 |
Intermittent Continuity | 11 |
Insufficient Information | 10 |
Break | 6 |
Electrical /Electronic Property Problem | 6 |
Cord | 5 |
Device Remains Activated | 4 |
Loss Of Power | 4 |
Environmental Compatibility Problem | 3 |
Component Missing | 3 |
Environmental Particulates | 2 |
Failure To Power Up | 1 |
Knob | 1 |
Charred | 1 |
Mechanics Altered | 1 |
Smoking | 1 |
High Impedance | 1 |
Device Inoperable | 1 |
Power Problem | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 121 |