FDA product code GAH: Stylet, Surgical, General & Plastic Surgery
GAH is the FDA product code for stylet, 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 7 510(k) submissions under GAH, from 7 different applicants. The average 510(k) review took 122 days (median 86). FDA has posted 3 recalls for GAH devices.
Classification
| Field | Value |
|---|---|
| Device name | Stylet, 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 GAH clearance
Top GAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Venx, LLC | 1 | 2011-04-22 |
| Advanced Medical Products, Inc. | 1 | 2000-05-17 |
| Barry Markman, M.D. | 1 | 1997-11-20 |
| Apex Medical Products, LLC | 1 | 1997-10-27 |
| Sil-Med Corp. | 1 | 1997-10-01 |
2 more applicants have GAH clearances. See the full list in Caduvo.
Most recent GAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110355 | Venx, LLC | VENX REVOLUTION | 2011-04-22 | 74 |
| K000932 | Advanced Medical Products, Inc. | ARACHNOPHLEBECTOMY NEEDLE | 2000-05-17 | 55 |
| K970306 | Barry Markman, M.D. | MARKMAN TEMPLATE SYSTEM | 1997-11-20 | 297 |
| K972918 | Apex Medical Products, LLC | RAPID FIRE HAIR IMPLANTER CAROUSEL | 1997-10-27 | 81 |
| K972521 | Sil-Med Corp. | NAVIGATOR (STYLET) 2006 | 1997-10-01 | 86 |
Recalls for GAH devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-01.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code GAH?
GAH is the FDA product code for stylet, 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 GAH?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAH?
Across 7 cleared submissions the average was 122 days from receipt to decision (median 86).
Which companies have the most GAH clearances?
Venx, LLC (1); Advanced Medical Products, Inc. (1); Barry Markman, M.D. (1); Apex Medical Products, LLC (1); Sil-Med Corp. (1).
Have GAH devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2021-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GAH
- Run a recall and safety report across every GAH manufacturer
- Watch product code GAH 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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