FDA product code GFA: Blade, Saw, General & Plastic Surgery, Surgical
GFA is the FDA product code for blade, saw, general & plastic surgery, surgical. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 27 510(k) submissions under GFA, from 21 different applicants. The average 510(k) review took 80 days (median 41). FDA has posted 19 recalls for GFA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Blade, Saw, General & Plastic Surgery, Surgical |
| 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 GFA clearance
Top GFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Aire Surgical Instruments, Inc. | 4 | 1989-11-22 |
| Wrightmedicaltechnologyinc | 2 | 1997-06-18 |
| Omega Surgical Instruments, Inc. | 2 | 1994-03-16 |
| Boehringer Laboratories | 2 | 1994-01-26 |
| Stryker Instruments | 1 | 1996-01-30 |
16 more applicants have GFA clearances. See the full list in Caduvo.
Most recent GFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971978 | Wrightmedicaltechnologyinc | GRAFT HARVESTING SAWBLADES | 1997-06-18 | 20 |
| K954483 | Stryker Instruments | STRYKER SAGITTAL SAW ATTACHMENT | 1996-01-30 | 125 |
| K955229 | Wrightmedicaltechnologyinc | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | 1996-01-18 | 65 |
| K953012 | Boston Surgical Products, Inc. | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | 1995-07-12 | 14 |
| K950403 | Transidyne General Corp. | SURGICAL SAW BLADES | 1995-02-21 | 21 |
Recalls for GFA devices
19 product recalls in 15 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GFA?
GFA is the FDA product code for blade, saw, general & plastic surgery, surgical. 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 GFA?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFA?
Across 27 cleared submissions the average was 80 days from receipt to decision (median 41).
Which companies have the most GFA clearances?
Micro-Aire Surgical Instruments, Inc. (4); Wrightmedicaltechnologyinc (2); Omega Surgical Instruments, Inc. (2); Boehringer Laboratories (2); Stryker Instruments (1).
Have GFA devices been recalled?
Yes: 19 product recalls across 15 recall events; the most recent began 2022-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GFA
- Run a recall and safety report across every GFA manufacturer
- Watch product code GFA 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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