FDA product code GFI: Osteotome, Manual
GFI is the FDA product code for osteotome, manual. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under GFI, from 6 different applicants. The average 510(k) review took 89 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Osteotome, Manual |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GFI clearance
Top GFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Valleylab, Inc. | 1 | 1993-11-02 |
| Innovative Surgical, Inc. | 1 | 1993-08-19 |
| Biomerieux Vitek, Inc. | 1 | 1992-09-25 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
| Storz Instrument Co. | 1 | 1985-07-11 |
1 more applicants have GFI clearances. See the full list in Caduvo.
Most recent GFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933181 | Valleylab, Inc. | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 | 1993-11-02 | 125 |
| K932534 | Innovative Surgical, Inc. | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | 1993-08-19 | 83 |
| K920001 | Biomerieux Vitek, Inc. | HEMOLAB SILIMAT REAGENT | 1992-09-25 | 267 |
| K891887 | Zinnanti Surgical Instruments, Inc. | OSTEOTOMES, VARIOUS TYPES | 1989-04-12 | 19 |
| K852541 | Storz Instrument Co. | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | 1985-07-11 | 27 |
Recalls for GFI devices
openFDA lists no recalls for product code GFI.
Frequently asked questions
What is FDA product code GFI?
GFI is the FDA product code for osteotome, manual. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GFI?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFI?
Across 6 cleared submissions the average was 89 days from receipt to decision (median 55).
Which companies have the most GFI clearances?
Valleylab, Inc. (1); Innovative Surgical, Inc. (1); Biomerieux Vitek, Inc. (1); Zinnanti Surgical Instruments, Inc. (1); Storz Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFI
- Run a recall and safety report across every GFI manufacturer
- Watch product code GFI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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