FDA product code GFF: Bur, Surgical, General & Plastic Surgery
GFF is the FDA product code for bur, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 16 510(k) submissions under GFF, from 13 different applicants. The average 510(k) review took 42 days (median 21). FDA has posted 13 recalls for GFF devices.
Classification
| Field | Value |
|---|---|
| Device name | Bur, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| 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 GFF clearance
Top GFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Aire Surgical Instruments, Inc. | 4 | 1989-08-21 |
| The Anspach Effort, Inc. | 1 | 1998-07-06 |
| Transidyne General Corp. | 1 | 1995-03-01 |
| Komet Medical | 1 | 1994-08-22 |
| American Medical Specialties, Inc. | 1 | 1994-01-26 |
8 more applicants have GFF clearances. See the full list in Caduvo.
Most recent GFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974025 | The Anspach Effort, Inc. | ANSPACH SHIELDED ATTACHMENT | 1998-07-06 | 256 |
| K950449 | Transidyne General Corp. | SURGICAL BUR | 1995-03-01 | 26 |
| K943758 | Komet Medical | SURGICAL BUR | 1994-08-22 | 20 |
| K934583 | American Medical Specialties, Inc. | BURRS | 1994-01-26 | 125 |
| K894438 | Micro-Aire Surgical Instruments, Inc. | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | 1989-08-21 | 35 |
Recalls for GFF devices
13 product recalls in 13 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-09.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code GFF?
GFF is the FDA product code for bur, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GFF?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFF?
Across 16 cleared submissions the average was 42 days from receipt to decision (median 21).
Which companies have the most GFF clearances?
Micro-Aire Surgical Instruments, Inc. (4); The Anspach Effort, Inc. (1); Transidyne General Corp. (1); Komet Medical (1); American Medical Specialties, Inc. (1).
Have GFF devices been recalled?
Yes: 13 product recalls across 13 recall events; the most recent began 2021-02-09.
Next steps
- Run an FDA pathway report with predicate devices for product code GFF
- Run a recall and safety report across every GFF manufacturer
- Watch product code GFF 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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