| Device Type ID | 4237 |
| Device Name | Hook, Ophthalmic |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| 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) Exempt |
| CFR Regulation Number | 886.4350 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HNQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4237 |
| Device | Hook, Ophthalmic |
| Product Code | HNQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| CFR Regulation Number | 886.4350 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Use Of Device Problem | 8 |
Material Separation | 5 |
Insufficient Information | 4 |
Physical Resistance / Sticking | 1 |
Fracture | 1 |
| Total Device Problems | 28 |