| Device Type ID | 4303 |
| Device Name | Unit, Cautery, Thermal, Battery-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 | HQP |
| 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 | 4303 |
| Device | Unit, Cautery, Thermal, Battery-powered |
| Product Code | HQP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal Cautery Unit. |
| CFR Regulation Number | 886.4115 [🔎] |
| Device Problems | |
|---|---|
Device Remains Activated | 2 |
Delivered As Unsterile Product | 1 |
Fire | 1 |
Sparking | 1 |
Unsealed Device Packaging | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Cautery | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beaver Visitec | II | Sep-13-2018 |