GAA — Needle, Aspiration And Injection, Disposable Class I
FDA product code GAA covers "Needle, Aspiration And Injection, Disposable", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAA
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223625 | pneumeric | CapnoSpot Pneumothorax Decompression Indicator | March 28, 2023 |
| K102274 | arvik enterprises/ mini lap technologies | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | June 15, 2011 |
| K011586 | diametrics medical | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | November 16, 2001 |
| K994151 | ximed/prosure/injectx | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | March 1, 2000 |
| K983200 | ximed/prosure/injectx | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | December 11, 1998 |
| K974741 | medical device technologies | MANAN ACCURA NEEDLE | January 8, 1998 |
| K962425 | radi medical systems | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | September 11, 1996 |
| K961959 | medical device technologies | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | July 19, 1996 |
| K945109 | sherwood medical | MONOJECT BONE MARROW BIOPSY TRAYS | November 14, 1994 |
| K940025 | manan medical products | MANAN BONE MARROW HARVEST NEEDLES | February 25, 1994 |
| K940024 | manan medical products | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | February 25, 1994 |
| K930158 | symbiosis | BONE MARROW BIOPSY PROCEDURE TRAY | July 2, 1993 |
| K925621 | kirwan surgical products | IRRIGATION/ASPIRATION TUBING SET | May 7, 1993 |
| K924501 | symbiosis | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | April 20, 1993 |
| K925416 | symbiosis | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | February 23, 1993 |
| K922614 | symbiosis | TURKEL THORACENTESIS SYSTEM | July 30, 1992 |
| K915417 | medical device technologies | KOPAN'S TARGET | January 14, 1992 |
| K914608 | dlp | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | January 9, 1992 |
| K913992 | northgate technologies | ASPIRATION/INJECTION NEEDLE | October 30, 1991 |
| K912074 | manan medical products | BONE MARROW BIOPSY TRAY | August 28, 1991 |