FDA product code GAA: Needle, Aspiration And Injection, Disposable
GAA is the FDA product code for needle, aspiration and injection, disposable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 107 510(k) submissions under GAA, 1 in the last five years, from 63 different applicants. The average 510(k) review took 54 days (median 44). FDA has posted 36 recalls for GAA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Aspiration And Injection, Disposable |
| 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 |
510(k) clearances per year for GAA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 113 |
Compare with all 510(k) review times · Search every GAA clearance
Top GAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A.D.T. Lab Industries | 14 | 1980-08-20 |
| Dlp, Inc. | 5 | 1992-01-09 |
| Symbiosis Corp. | 4 | 1993-07-02 |
| R. J. Doyle, Inc. | 4 | 1989-09-22 |
| National Patent Development Corp. | 4 | 1979-03-26 |
58 more applicants have GAA clearances. See the full list in Caduvo.
Most recent GAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223625 | Pneumeric, Inc. | CapnoSpot Pneumothorax Decompression Indicator | 2023-03-28 | 113 |
| K102274 | Arvik Enterprises/ Mini Lap Technologies | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | 2011-06-15 | 308 |
| K011586 | Diametrics Medical, Inc. | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | 2001-11-16 | 177 |
| K994151 | Ximed/Prosure/Injectx | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | 2000-03-01 | 83 |
| K983200 | Ximed/Prosure/Injectx | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | 1998-12-11 | 88 |
Recalls for GAA devices
36 product recalls in 17 recall events; 2 initiated in the last five years and 5 still open. Most recent: 2022-07-29.
| Year | Recalls |
|---|---|
| 2019 | 10 |
| 2020 | 3 |
| 2021 | 10 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code GAA?
GAA is the FDA product code for needle, aspiration and injection, disposable. 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 GAA?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAA?
Across 107 cleared submissions the average was 54 days from receipt to decision (median 44).
Which companies have the most GAA clearances?
A.D.T. Lab Industries (14); Dlp, Inc. (5); Symbiosis Corp. (4); R. J. Doyle, Inc. (4); National Patent Development Corp. (4).
Have GAA devices been recalled?
Yes: 36 product recalls across 17 recall events; the most recent began 2022-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GAA
- Run a recall and safety report across every GAA manufacturer
- Watch product code GAA 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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