GAAClass I
Needle, Aspiration And Injection, Disposable
21 CFR 878.4800 / General, Plastic Surgery
GAA is the FDA product code for Needle, Aspiration And Injection, Disposable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 107 510(k) clearances under this code, the most recent dated , and 36 recalls.
Classification record
- Product code
- GAA
- Device name
- Needle, Aspiration And Injection, Disposable
- Regulation
- 21 CFR 878.4800
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 107
- Ingested recalls
- 36
Clearances, product code GAA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1978 | 4 |
| 1979 | 5 |
| 1980 | 16 |
| 1981 | 3 |
| 1982 | 9 |
| 1983 | 3 |
| 1984 | 7 |
| 1985 | 9 |
| 1986 | 5 |
| 1987 | 5 |
| 1988 | 3 |
| 1989 | 6 |
| 1990 | 5 |
| 1991 | 4 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 3 |
| 1996 | 2 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2011 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code GAA| Applicant | Clearances |
|---|---|
| A.D.T. Lab Industries | 14 |
| National Patent Development Corp. | 4 |
| R. J. Doyle, Inc. | 4 |
| Boston Scientific Corporation | 4 |
| Manan Manufacturing Co., Inc. | 3 |
| Argon Medical Devices, Inc | 3 |
| Medical Device Technologies, Inc. | 3 |
| Ocean Medical Products, Ltd. | 3 |
| Wilson-Cook Medical Inc. | 3 |
| Creative Research and Mfg., Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
