Device Type ID | 5577 |
Device Name | Curette, Surgical, General Use |
Regulation Description | Manual Surgical Instrument For General Use. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4800 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FZS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5577 |
Device | Curette, Surgical, General Use |
Product Code | FZS |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Surgical Instrument For General Use. |
CFR Regulation Number | 878.4800 [🔎] |
Device Problems | |
---|---|
Break | 3 |
Dull, Blunt | 2 |
Insufficient Information | 1 |
Appropriate Term/Code Not Available | 1 |
Total Device Problems | 7 |