FDA product code GAF: Spatula, Surgical, General & Plastic Surgery
GAF is the FDA product code for spatula, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under GAF, from 5 different applicants. The average 510(k) review took 44 days (median 23). FDA has posted 1 recall for GAF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Spatula, Surgical, General & Plastic Surgery |
| 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 GAF clearance
Top GAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| LeMaitre Vascular, Inc. | 1 | 2003-01-30 |
| Surgiquip, Inc. | 1 | 1994-01-28 |
| Kinetic Medical Products | 1 | 1989-02-03 |
| Pmt Corp. | 1 | 1988-07-18 |
| Bio-Blitz, Inc. | 1 | 1982-08-11 |
Most recent GAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023688 | LeMaitre Vascular, Inc. | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | 2003-01-30 | 90 |
| K935357 | Surgiquip, Inc. | SNAP RECIPROCATING SAW | 1994-01-28 | 85 |
| K890374 | Kinetic Medical Products | ABDOMINAL SPATULA | 1989-02-03 | 11 |
| K882793 | Pmt Corp. | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE | 1988-07-18 | 12 |
| K822108 | Bio-Blitz, Inc. | CEMENT-PICK | 1982-08-11 | 23 |
Recalls for GAF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code GAF?
GAF is the FDA product code for spatula, surgical, general & plastic surgery. 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 GAF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAF?
Across 5 cleared submissions the average was 44 days from receipt to decision (median 23).
Which companies have the most GAF clearances?
LeMaitre Vascular, Inc. (1); Surgiquip, Inc. (1); Kinetic Medical Products (1); Pmt Corp. (1); Bio-Blitz, Inc. (1).
Have GAF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GAF
- Run a recall and safety report across every GAF manufacturer
- Watch product code GAF 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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