FDA product code GAC: Rasp, Surgical, General & Plastic Surgery
GAC is the FDA product code for rasp, 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 2 510(k) submissions under GAC, from 2 different applicants. The average 510(k) review took 32 days (median 32). FDA has posted 1 recall for GAC devices.
Classification
| Field | Value |
|---|---|
| Device name | Rasp, 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 GAC clearance
Top GAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neo Contemporary Co. | 1 | 1988-12-09 |
| Bowen & Company, Inc. | 1 | 1985-09-16 |
Most recent GAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884473 | Neo Contemporary Co. | RUBIN BONE PLANER W/REPLACEABLE BLADE | 1988-12-09 | 45 |
| K853601 | Bowen & Company, Inc. | MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP | 1985-09-16 | 20 |
Recalls for GAC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-12-29.
Frequently asked questions
What is FDA product code GAC?
GAC is the FDA product code for rasp, 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 GAC?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAC?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most GAC clearances?
Neo Contemporary Co. (1); Bowen & Company, Inc. (1).
Have GAC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-12-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GAC
- Run a recall and safety report across every GAC manufacturer
- Watch product code GAC 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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