GEE — Brush, Biopsy, General & Plastic Surgery Class I
FDA product code GEE covers "Brush, Biopsy, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEE
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K854003 | co-medical | STERILE SOFT TISSUE BIOPSY NEEDLE | October 18, 1985 |
| K841008 | premier dental products | BIOPSY PUNCH, VARIOUS | June 8, 1984 |
| K822490 | van-tec | DEFLECTING CYTOLOGY BRUSH | September 14, 1982 |
| K820259 | american endoscopy | STERILE CYTOLOGY BRUSHES | March 5, 1982 |
| K812694 | medi-spec | WHISK-R | October 26, 1981 |
| K801304 | johannah medical services | CAMLOC SYRINGE BIOPSY KIT | June 17, 1980 |
| K792316 | ursus konsult | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET | December 18, 1979 |