Panels › General, Plastic Surgery › Product code GAA · Class 1
Needle, Aspiration And Injection, Disposable
Regulation 878.4800
0510(k)s in 12 months (107 all time)
0recalls in 12 months (37 all time)
5recalls that name a 510(k)
Top companies in GAA
| Company | 510(k)s | Recalls |
|---|---|---|
| A.D.T. Lab Industries | 14 | 0 |
| Vitreq Bv | 0 | 10 |
| Medical Device Technologies, Inc. | 3 | 3 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Dlp, Inc. | 5 | 0 |
| National Patent Development Corp. | 4 | 0 |
| R. J. Doyle, Inc. | 4 | 0 |
| Symbiosis Corp. | 4 | 0 |
| Hobbs Medical, Inc. | 1 | 2 |
| INNOVATIVE TOMOGRAPHY PRODUCT GMBH | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2023 | K223625 | CapnoSpot Pneumothorax Decompression Indicator Pneumeric, Inc. | GAA |
| Jun 15, 2011 | K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT Arvik Enterprises/ Mini Lap Technologies | GAA |
| Nov 16, 2001 | K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE Diametrics Medical, Inc. | GAA |
| Mar 1, 2000 | K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES Ximed/Prosure/Injectx | GAA |
| Dec 11, 1998 | K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX Ximed/Prosure/Injectx | GAA |
| Jan 8, 1998 | K974741 | MANAN ACCURA NEEDLE Medical Device Technologies, Inc. | GAA |
| Sep 11, 1996 | K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) Radi Medical Systems AB, SE | GAA |
| Jul 19, 1996 | K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc. | GAA |
| Nov 14, 1994 | K945109 | MONOJECT BONE MARROW BIOPSY TRAYS Sherwood Medical Co. | GAA |
| Feb 25, 1994 | K940025 | MANAN BONE MARROW HARVEST NEEDLES Manan Medical Products, Inc. | GAA |
| Feb 25, 1994 | K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE Manan Medical Products, Inc. | GAA |
| Jul 2, 1993 | K930158 | BONE MARROW BIOPSY PROCEDURE TRAY Symbiosis Corp. | GAA |
| May 7, 1993 | K925621 | IRRIGATION/ASPIRATION TUBING SET Kirwan Surgical Products, Inc. | GAA |
| Apr 20, 1993 | K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE Symbiosis Corp. | GAA |
| Feb 23, 1993 | K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE Symbiosis Corp. | GAA |
| Jul 30, 1992 | K922614 | TURKEL THORACENTESIS SYSTEM Symbiosis Corp. | GAA |
| Jan 14, 1992 | K915417 | KOPAN'S TARGET Medical Device Technologies, Inc. | GAA |
| Jan 9, 1992 | K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 Dlp, Inc. | GAA |
| Oct 30, 1991 | K913992 | ASPIRATION/INJECTION NEEDLE Northgate Technologies, Inc. | GAA |
| Aug 28, 1991 | K912074 | BONE MARROW BIOPSY TRAY Manan Medical Products, Inc. | GAA |
| Apr 4, 1991 | K910036 | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES Surgical Technologies, Inc. | GAA |
| Mar 19, 1991 | K910117 | REDDICK IRRIGATION/ASPIRATION SYSTEM Ideal Medical, Inc. | GAA |
| May 24, 1990 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE Telemed Systems, Inc. | GAA |
| Apr 16, 1990 | K897050 | WILSON-COOK LUNG BIOPSY NEEDLE Wilson-Cook Medical, Inc. | GAA |
| Jan 4, 1990 | K896606 | JACKSON FINE NEEDLE ASPIRATION SYSTEM National-Standard Medical Products | GAA |
| Jan 4, 1990 | K896605 | KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) National-Standard Medical Products | GAA |
| Jan 3, 1990 | K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. Dlp, Inc. | GAA |
| Dec 27, 1989 | K895012 | E-Z-EM VACUUM ASPIRATION SYRINGE E-Z-Em, Inc. | GAA |
| Sep 22, 1989 | K894875 | 20GA X 7-1/2 THREADING BULLET POINT NEEDLE R. J. Doyle, Inc. | GAA |
| Sep 22, 1989 | K894874 | 14 INCH BULLET POINT NEEDLE R. J. Doyle, Inc. | GAA |
| Sep 22, 1989 | K894873 | 16 GA X 10 BULLET POINT NEEDLE R. J. Doyle, Inc. | GAA |
| Sep 22, 1989 | K894872 | 16 GA X 6 BULLET POINT NEEDLE R. J. Doyle, Inc. | GAA |
| Jul 24, 1989 | K894326 | THORACENTISIS KIT Mill-Rose Laboratory | GAA |
| Jul 28, 1988 | K883014 | MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED Sherwood Medical Co. | GAA |
| Jul 11, 1988 | K882105 | CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM Dianon Systems, Inc. | GAA |
| Apr 4, 1988 | K880377 | NOVO VIVO MODEL #17140 AND #17135 Genesis Industries, Inc. | GAA |
| Dec 30, 1987 | K874000 | PRIA-KIT (TM) PRIAPISM KIT S.S. Canton Medical, Inc. | GAA |
| Sep 8, 1987 | K873124 | ANCHOR BIOPSY NEEDLE Anchor Products Co. | GAA |
| Mar 25, 1987 | K870893 | MEDSURG CHIBA PTC NEEDLE Medsurg Industries, Inc. | GAA |
| Mar 18, 1987 | K870896 | NOTCH-NEEDLE, WESCOTT STYLE Ocean Medical Products, Ltd. | GAA |
| Feb 6, 1987 | K864800 | NAMIC CHIBA ASPIRATION BIOPSY NEEDLE North American Instrument Corp. | GAA |
| Nov 5, 1986 | K864139 | RANFAC CUT BIOPSY NEEDLE Ranfac, Corp. | GAA |
| Oct 14, 1986 | K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE Manan Manufacturing Co., Inc. | GAA |
| Sep 16, 1986 | K863326 | BONE MARROW TRAY Packaging Technologies, Inc. | GAA |
| Mar 4, 1986 | K860582 | TBI NEEDLE Hobbs Medical, Inc. | GAA |
| Jan 24, 1986 | K855141 | ANGIOMED FINE NEEDLES AND NEEDLE SET Angiomed U.S., Inc. | GAA |
| Dec 17, 1985 | K854579 | HYPODERMIC NEEDLE AND STYLET Berkley and Co. | GAA |
| Nov 13, 1985 | K854238 | NEEDLE W/STYLET FOR IMPLANTATION Microvasive | GAA |
| Oct 18, 1985 | K853980 | EROSA DISPOSABLE HYPODERMIC NEEDLE Rose KG | GAA |
| Aug 21, 1985 | K852897 | LEE BONE MARROW BIOPSY/ASPIRATION TRAY Southland Instruments, Inc. | GAA |
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