FDA product code GAK: Suture, Absorbable
GAK is the FDA product code for suture, absorbable. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under GAK. The average 510(k) review took 22 days (median 22). 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Absorbable |
| Device class | Class II |
| Regulation | 21 CFR 878.4830 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every GAK clearance
Top GAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Davis & Geck, Inc. | 1 | 1991-10-23 |
Most recent GAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914365 | Davis & Geck, Inc. | DEXON DISSECTING SPONGE | 1991-10-23 | 22 |
Recalls for GAK devices
openFDA lists no recalls for product code GAK.
Frequently asked questions
What is FDA product code GAK?
GAK is the FDA product code for suture, absorbable. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel.
What device class is GAK?
Class II, regulation 21 CFR 878.4830. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAK?
Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most GAK clearances?
Davis & Geck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GAK
- Run a recall and safety report across every GAK manufacturer
- Watch product code GAK 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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