Device Type ID | 4226 |
Device Name | Scissors, 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) Intraocular And Corneal Implants Devices Branch (ICIB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 886.4350 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HNF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4226 |
Device | Scissors, Ophthalmic |
Product Code | HNF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Ophthalmic Surgical Instrument. |
CFR Regulation Number | 886.4350 [🔎] |
Device Problems | |
---|---|
Break | 34 |
Insufficient Information | 1 |
Inadequate Or Insufficient Training | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 37 |