Product code GAA
- Device name
- Needle, Aspiration And Injection, Disposable
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223625 | CapnoSpot™ Pneumothorax Decompression Indicator | Pneumeric, Inc. | 2023-03-28 |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | 2001-11-16 |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | 2000-03-01 |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | 1998-12-11 |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Radi Medical Systems AB | 1996-09-11 |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1996-07-19 |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Sherwood Medical Co. | 1994-11-14 |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | 1994-02-25 |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Symbiosis Corp. | 1993-07-02 |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | 1993-05-07 |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-04-20 |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-02-23 |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | 1992-07-30 |
| K915417 | KOPAN'S TARGET | Medical Device Technologies, Inc. | 1992-01-14 |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Dlp, Inc. | 1992-01-09 |
| K913992 | ASPIRATION/INJECTION NEEDLE | Northgate Technologies, Inc. | 1991-10-30 |
| K912074 | BONE MARROW BIOPSY TRAY | Manan Medical Products, Inc. | 1991-08-28 |
| K910036 | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES | Surgical Technologies, Inc. | 1991-04-04 |
| K910117 | REDDICK IRRIGATION/ASPIRATION SYSTEM | Ideal Medical, Inc. | 1991-03-19 |
| K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | Telemed Systems, Inc. | 1990-05-24 |
| K897050 | WILSON-COOK LUNG BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | 1990-04-16 |
| K896605 | KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) | National-Standard Medical Products | 1990-01-04 |
| K896606 | JACKSON FINE NEEDLE ASPIRATION SYSTEM | National-Standard Medical Products | 1990-01-04 |
| K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. | Dlp, Inc. | 1990-01-03 |
| K895012 | E-Z-EM VACUUM ASPIRATION SYRINGE | E-Z-Em, Inc. | 1989-12-27 |
| K894872 | 16 GA X 6 BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 |
| K894873 | 16 GA X 10 BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09347144017596 | Metier Medical | METIER MEDICAL LTD | 2026-10-19 |
| 00860015723901 | NerveAction Solutions | NerveAction Solutions Inc. | 2026-10-15 |
| 00860015723918 | NerveAction Solutions | NerveAction Solutions Inc. | 2026-10-15 |
| 00860015723925 | NerveAction Solutions | NerveAction Solutions Inc. | 2026-10-15 |
| 00860015723932 | NerveAction Solutions | NerveAction Solutions Inc. | 2026-10-15 |
| 10198956491298 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-10-12 |
| 00817295020282 | Inrad | Inrad | 2026-10-09 |
| 00817295020398 | Inrad | Inrad | 2026-10-09 |
| 00817295020299 | Inrad | Inrad | 2026-10-09 |
| 00817295020305 | Inrad | Inrad | 2026-10-09 |
| 00817295020312 | Inrad | Inrad | 2026-10-09 |
| 00817295020329 | Inrad | Inrad | 2026-10-09 |
| 00817295020336 | Inrad | Inrad | 2026-10-09 |
| 00817295020343 | Inrad | Inrad | 2026-10-09 |
| 00817295020350 | Inrad | Inrad | 2026-10-09 |
| 00817295020367 | Inrad | Inrad | 2026-10-09 |
| 00817295020374 | Inrad | Inrad | 2026-10-09 |
| 00817295020381 | Inrad | Inrad | 2026-10-09 |
| 00817295020275 | Inrad | Inrad | 2026-10-09 |
| 00817295020268 | Inrad | Inrad | 2026-10-09 |
| 00817295020251 | Inrad | Inrad | 2026-10-09 |
| 00817295020244 | Inrad | Inrad | 2026-10-09 |
| 00817295020237 | Inrad | Inrad | 2026-10-09 |
| 00817295020220 | Inrad | Inrad | 2026-10-09 |
| 00817295020213 | Inrad | Inrad | 2026-10-09 |
| 00817295020206 | Inrad | Inrad | 2026-10-09 |
| 00817295020190 | Inrad | Inrad | 2026-10-09 |
| 00817295020183 | Inrad | Inrad | 2026-10-09 |
| 00817295020145 | Inrad | Inrad | 2026-10-09 |
| 00817295020138 | Inrad | Inrad | 2026-10-09 |