GFI — Osteotome, Manual Class I
FDA product code GFI covers "Osteotome, Manual", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GFI
- 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 |
|---|---|---|---|
| K933181 | valleylab | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 | November 2, 1993 |
| K932534 | innovative surgical | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | August 19, 1993 |
| K920001 | biomerieux vitek | HEMOLAB SILIMAT REAGENT | September 25, 1992 |
| K891887 | zinnanti surgical instruments | OSTEOTOMES, VARIOUS TYPES | April 12, 1989 |
| K852541 | storz instrument | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | July 11, 1985 |
| K842823 | cher mel | CHERMEL OSTEOTOMES | August 2, 1984 |