FDA product code GAX: Tourniquet, Nonpneumatic
GAX is the FDA product code for tourniquet, nonpneumatic. It is a Class I device, regulated under 21 CFR 878.5900 and reviewed by the General and Plastic Surgery panel. FDA has cleared 20 510(k) submissions under GAX, from 19 different applicants. The average 510(k) review took 41 days (median 28). FDA has posted 8 recalls for GAX devices.
Classification
| Field | Value |
|---|---|
| Device name | Tourniquet, Nonpneumatic |
| Device class | Class I |
| Regulation | 21 CFR 878.5900 |
| 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 GAX clearance
Top GAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abco Dealers, Inc. | 2 | 1982-06-16 |
| Icat Systems | 1 | 1993-09-01 |
| Barretta Products, Research and Development, Inc. | 1 | 1988-04-29 |
| Spectrum/Hydro-Med Products, Inc. | 1 | 1988-04-11 |
| Degania Silicone , Ltd. | 1 | 1988-01-07 |
14 more applicants have GAX clearances. See the full list in Caduvo.
Most recent GAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931198 | Icat Systems | UNIQUET | 1993-09-01 | 176 |
| K881398 | Barretta Products, Research and Development, Inc. | TOURNIQUET | 1988-04-29 | 25 |
| K881176 | Spectrum/Hydro-Med Products, Inc. | STERILE ESMARCH BANDAGE | 1988-04-11 | 24 |
| K875092 | Degania Silicone , Ltd. | DEGANIA SILICONE TOURNIQUET | 1988-01-07 | 28 |
| K873928 | Dryden Corp. | UNIVERSAL TOURNIQUET | 1987-10-23 | 28 |
Recalls for GAX devices
8 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-28.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code GAX?
GAX is the FDA product code for tourniquet, nonpneumatic. It is a Class I device, regulated under 21 CFR 878.5900 and reviewed by the General and Plastic Surgery panel.
What device class is GAX?
Class I, regulation 21 CFR 878.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAX?
Across 20 cleared submissions the average was 41 days from receipt to decision (median 28).
Which companies have the most GAX clearances?
Abco Dealers, Inc. (2); Icat Systems (1); Barretta Products, Research and Development, Inc. (1); Spectrum/Hydro-Med Products, Inc. (1); Degania Silicone , Ltd. (1).
Have GAX devices been recalled?
Yes: 8 product recalls across 4 recall events; the most recent began 2020-12-28.
Next steps
- Run an FDA pathway report with predicate devices for product code GAX
- Run a recall and safety report across every GAX manufacturer
- Watch product code GAX 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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