Product Code: GAA
FDA class 1
21 CFR 878.4800
Needle, Aspiration And Injection, Disposable
General, Plastic Surgery
The Needle, Aspiration And Injection, Disposable (product code GAA) is a single-use needle designed for both aspirating fluid from or injecting fluid into tissue or body cavities during general and plastic surgery procedures. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k)s
107
FEI Numbers
329
Registration Numbers
330
Unique Applicants
63
Years Active
47
Basic Information
- Product Code
- GAA
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 107 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression Indicator | Mar 28, 2023 | Substantially Equivalent | Pneumeric, Inc. |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Jun 15, 2011 | Substantially Equivalent | ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Nov 16, 2001 | Substantially Equivalent | DIAMETRICS MEDICAL, INC. |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Mar 01, 2000 | Substantially Equivalent | XIMED/PROSURE/INJECTX |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Dec 11, 1998 | Substantially Equivalent | XIMED/PROSURE/INJECTX |
| K974741 | MANAN ACCURA NEEDLE | Jan 08, 1998 | Substantially Equivalent | MEDICAL DEVICE TECHNOLOGIES, INC. |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Sep 11, 1996 | Substantially Equivalent | RADI MEDICAL SYSTEMS AB |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Jul 19, 1996 | Substantially Equivalent | MEDICAL DEVICE TECHNOLOGIES, INC. |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Nov 14, 1994 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Feb 25, 1994 | Substantially Equivalent | MANAN MEDICAL PRODUCTS, INC. |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Feb 25, 1994 | Substantially Equivalent | MANAN MEDICAL PRODUCTS, INC. |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Jul 02, 1993 | Unknown | SYMBIOSIS CORP. |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | May 07, 1993 | Substantially Equivalent | KIRWAN SURGICAL PRODUCTS, INC. |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Apr 20, 1993 | Substantially Equivalent | SYMBIOSIS CORP. |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Feb 23, 1993 | Substantially Equivalent | SYMBIOSIS CORP. |
| K922614 | TURKEL THORACENTESIS SYSTEM | Jul 30, 1992 | Substantially Equivalent | SYMBIOSIS CORP. |
| K915417 | KOPAN'S TARGET | Jan 14, 1992 | Substantially Equivalent | MEDICAL DEVICE TECHNOLOGIES, INC. |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Jan 09, 1992 | Substantially Equivalent | DLP, INC. |
| K913992 | ASPIRATION/INJECTION NEEDLE | Oct 30, 1991 | Substantially Equivalent | NORTHGATE TECHNOLOGIES, INC. |
| K912074 | BONE MARROW BIOPSY TRAY | Aug 28, 1991 | Substantially Equivalent | MANAN MEDICAL PRODUCTS, INC. |
| K910036 | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES | Apr 04, 1991 | Substantially Equivalent | SURGICAL TECHNOLOGIES, INC. |
| K910117 | REDDICK IRRIGATION/ASPIRATION SYSTEM | Mar 19, 1991 | Substantially Equivalent | IDEAL MEDICAL, INC. |
| K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | May 24, 1990 | Substantially Equivalent | TELEMED SYSTEMS, INC. |
| K897050 | WILSON-COOK LUNG BIOPSY NEEDLE | Apr 16, 1990 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K896606 | JACKSON FINE NEEDLE ASPIRATION SYSTEM | Jan 04, 1990 | Substantially Equivalent | NATIONAL-STANDARD MEDICAL PRODUCTS |
| K896605 | KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) | Jan 04, 1990 | Substantially Equivalent | NATIONAL-STANDARD MEDICAL PRODUCTS |
| K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. | Jan 03, 1990 | Substantially Equivalent | DLP, INC. |
| K895012 | E-Z-EM VACUUM ASPIRATION SYRINGE | Dec 27, 1989 | Substantially Equivalent | E-Z-EM, INC. |
| K894875 | 20GA X 7-1/2 THREADING BULLET POINT NEEDLE | Sep 22, 1989 | Substantially Equivalent | R. J. DOYLE, INC. |
| K894874 | 14 INCH BULLET POINT NEEDLE | Sep 22, 1989 | Substantially Equivalent | R. J. DOYLE, INC. |
| K894873 | 16 GA X 10 BULLET POINT NEEDLE | Sep 22, 1989 | Substantially Equivalent | R. J. DOYLE, INC. |
| K894872 | 16 GA X 6 BULLET POINT NEEDLE | Sep 22, 1989 | Substantially Equivalent | R. J. DOYLE, INC. |
| K894326 | THORACENTISIS KIT | Jul 24, 1989 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K883014 | MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED | Jul 28, 1988 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K882105 | CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM | Jul 11, 1988 | Unknown | DIANON SYSTEMS, INC. |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | Apr 04, 1988 | Substantially Equivalent | GENESIS INDUSTRIES, INC. |
| K874000 | PRIA-KIT (TM) PRIAPISM KIT S.S. | Dec 30, 1987 | Unknown | CANTON MEDICAL, INC. |
| K873124 | ANCHOR BIOPSY NEEDLE | Sep 08, 1987 | Substantially Equivalent | ANCHOR PRODUCTS CO. |
| K870893 | MEDSURG CHIBA PTC NEEDLE | Mar 25, 1987 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K870896 | NOTCH-NEEDLE, WESCOTT STYLE | Mar 18, 1987 | Substantially Equivalent | OCEAN MEDICAL PRODUCTS, LTD. |
| K864800 | NAMIC CHIBA ASPIRATION BIOPSY NEEDLE | Feb 06, 1987 | Substantially Equivalent | NORTH AMERICAN INSTRUMENT CORP. |
| K864139 | RANFAC CUT BIOPSY NEEDLE | Nov 05, 1986 | Substantially Equivalent | RANFAC CORP. |
| K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE | Oct 14, 1986 | Substantially Equivalent | MANAN MANUFACTURING CO., INC. |
| K863326 | BONE MARROW TRAY | Sep 16, 1986 | Substantially Equivalent | PACKAGING TECHNOLOGIES, INC. |
| K860582 | TBI NEEDLE | Mar 04, 1986 | Substantially Equivalent | HOBBS MEDICAL, INC. |
| K855141 | ANGIOMED FINE NEEDLES AND NEEDLE SET | Jan 24, 1986 | Substantially Equivalent | ANGIOMED U.S., INC. |
| K854579 | HYPODERMIC NEEDLE AND STYLET | Dec 17, 1985 | Substantially Equivalent | BERKLEY AND CO. |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent | MICROVASIVE |
| K853980 | EROSA DISPOSABLE HYPODERMIC NEEDLE | Oct 18, 1985 | Substantially Equivalent | ROSE KG |
| K852897 | LEE BONE MARROW BIOPSY/ASPIRATION TRAY | Aug 21, 1985 | Unknown | SOUTHLAND INSTRUMENTS, INC. |
| K852817 | STERILE, DISPOSABLE NEEDLE | Jul 26, 1985 | Substantially Equivalent | FABERSANITAS, S.A. |
| K852427 | MANAN SPINAL NEEDLE | Jun 27, 1985 | Substantially Equivalent | MANAN MANUFACTURING CO., INC. |
| K852426 | MANAN TROCAR STYLE BIOPSY NEEDLE | Jun 27, 1985 | Substantially Equivalent | MANAN MANUFACTURING CO., INC. |
| K851957 | CHIBA NEEDLE | May 17, 1985 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K851953 | HAWKIN NEEDLE | May 17, 1985 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K843925 | GILL'S IRRIGATOR/ASPIRATOR NEEDLE | Nov 05, 1984 | Substantially Equivalent | CONCEPT, INC. |
| K843083 | CORMED HUBER POINT NEEDLE | Sep 05, 1984 | Substantially Equivalent | CORMED, INC., SUB. C.R.BARD, INC. |
| K842230 | AIMED DISPOS. INJECTION NEEDLE | Aug 17, 1984 | Substantially Equivalent | TECH-CONS LTD., INTL. |
| K842106 | LEE BONE MARROW NEEDLES | Aug 10, 1984 | Substantially Equivalent | SOUTHLAND INSTRUMENTS, INC. |
| K842699 | ISLAM BONE MARROW ASPIRATION NEEDLES | Aug 02, 1984 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K841301 | GARDNER TYPE BONE MARROW NEEDLE | Jun 05, 1984 | Substantially Equivalent | POPPER & SONS, INC. |
| K840922 | INTRADISCAL THERAPY NEEDLE 18 GAUGE | Apr 24, 1984 | Substantially Equivalent | DLP, INC. |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | Oct 14, 1983 | Substantially Equivalent | TOP SURGICAL MANUFACTURERS CO. |
| K831392 | TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 | Jul 12, 1983 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K830378 | STERILE, DISPOSABLE, HYPODERMIC NEEDLES | Mar 24, 1983 | Substantially Equivalent | ABCO DEALERS, INC. |
| K821697 | INJECTION ASPIRATING NEEDLES | Jun 25, 1982 | Substantially Equivalent | AMERICAN ENDOSCOPY, INC. |
| K821017 | VARIOUS STERILE BIOPSY ASPIRATION NEED | Jun 22, 1982 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K821348 | HYPODERMIC NEEDLES & SYRINGES | Jun 10, 1982 | Substantially Equivalent | MEDI-TECH, INC. |
| K820502 | SILOAM SAVE-A-NEEDLE | Mar 15, 1982 | Substantially Equivalent | SILOAM, INC. |
| K820070 | MSI STERNUM ASPIRATION NEEDLE | Feb 04, 1982 | Substantially Equivalent | CREATIVE RESEARCH AND MFG., INC. |
| K813460 | CHIBA SKINNY NEEDLE | Jan 07, 1982 | Substantially Equivalent | OCEAN MEDICAL PRODUCTS, LTD. |
| K813448 | POTTS-COURNAND STYLE NEEDLE | Jan 07, 1982 | Substantially Equivalent | OCEAN MEDICAL PRODUCTS, LTD. |
| K813368 | DISPOSABLE CHIBA-TYPE NEEDLE | Jan 05, 1982 | Substantially Equivalent | DLP, INC. |
| K813367 | CUATICO MYELOGRAPHY NEEDLES | Jan 05, 1982 | Substantially Equivalent | DLP, INC. |
| K811771 | A.D.T. REUSABLE BONE MARROW NEEDLE | Jul 10, 1981 | Substantially Equivalent | LAB INDUSTRIES, INC. |
| K810248 | MSI BONE MARROW BIOPSY NEEDLE W/J TIP | Mar 20, 1981 | Substantially Equivalent | CREATIVE RESEARCH AND MFG., INC. |
| K810076 | PHERESIS NEEDLE ASSEMBLY | Mar 05, 1981 | Substantially Equivalent | HAEMONETICS CORP. |
| K801754 | ADT BONE MARROW ASPIRATION NEEDLE | Aug 20, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K801753 | ADT BONE MARROW BIOPSY-ASPIR. NEELDE | Aug 20, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K801457 | ACCU-CORE DISPOSABLE BIOPSY NEEDLE | Jul 14, 1980 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K800417 | ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800414 | ADT SOFT TISSUE BIOPSY TRAY | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800412 | ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800411 | ASPIRATION TRAY W/FERRIS DISP. ILLINOIS | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800410 | ADT BONE MARROW BIOPSY-ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800409 | ADT BONE MARROW BIOPSY ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800408 | ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE | Apr 28, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800423 | ADT NERVE BLOCK TRAY(DISP.) | Mar 25, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800421 | ADT PERITONEAL LAVAGE TRAY (DISP.) | Mar 25, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800415 | ADT MENGHINI TYPE SOFT TISSUE BIOPSY | Mar 25, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800413 | FERRIS MODIFIED DISP. IL STERNAL-ILIAC | Mar 25, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800407 | FERRIS BONE MARROW -NEEDLE-(DISPOSABLE) | Mar 12, 1980 | Substantially Equivalent | A.D.T. LAB INDUSTRIES |
| K800153 | EXTEMP/EXTEMP-V | Feb 06, 1980 | Substantially Equivalent | PHARMA-FILTER, INC. |
| K790472 | BURRON VENTED NEEDLE | Mar 26, 1979 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K790060 | NEEDLE II, BURRON FILTER | Mar 21, 1979 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K790142 | NEEDLE, WITH FILTER | Feb 26, 1979 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K790061 | NEEDLE, BURRON FILTER | Feb 16, 1979 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K790079 | NEEDLE, BLOOD COLLECTING | Feb 01, 1979 | Substantially Equivalent | JELCO LABORATORIES |
| K781371 | BONE MARROW ASPIRATION KIT | Sep 20, 1978 | Substantially Equivalent | FERRIS MFG. CORP. |
| K781264 | PAB CONVENIENCE TRAY | Sep 20, 1978 | Substantially Equivalent | WATERS ASSOC., INC. |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | Jun 22, 1978 | Substantially Equivalent | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
| K780624 | CULDOCENTESIS TRAY | May 26, 1978 | Substantially Equivalent | CUTTER LABORATORIES, INC. |
| K771784 | IOPSY TRAY FOR SOFT TISSUE BIOPSY | Nov 30, 1977 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K771760 | EXTEMP | Sep 28, 1977 | Substantially Equivalent | PHARMACO, INC. |
| K771759 | EXTEMP-V | Sep 28, 1977 | Substantially Equivalent | PHARMACO, INC. |
| K760775 | TERUMO DISPOSABLE SPINAL NEEDLE | Nov 01, 1976 | Substantially Equivalent | TERUMO AMERICA, INC. |
| K760022 | NEEDLE, FILTER | Aug 09, 1976 | Substantially Equivalent | JELCO LABORATORIES |
FEI Numbers
This FDA classification entry is associated with 329 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 330 registration numbers. Click on an entry to view related FDA registrations.