GAA — Needle, Aspiration And Injection, Disposable Class I

FDA Device Classification

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-NumberApplicantDevice NameDate
K223625pneumericCapnoSpot™ Pneumothorax Decompression IndicatorMarch 28, 2023
K102274arvik enterprises/ mini lap technologiesARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTJune 15, 2011
K011586diametrics medicalIRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGENovember 16, 2001
K994151ximed/prosure/injectxPERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESMarch 1, 2000
K983200ximed/prosure/injectxINJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXDecember 11, 1998
K974741medical device technologiesMANAN ACCURA NEEDLEJanuary 8, 1998
K962425radi medical systemsBONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)September 11, 1996
K961959medical device technologiesMD TECH BIOPSY SET FOR BONE AND BONE MARROWJuly 19, 1996
K945109sherwood medicalMONOJECT BONE MARROW BIOPSY TRAYSNovember 14, 1994
K940024manan medical productsMANAN GENERAL PURPOSE INTRODUCER NEEDLEFebruary 25, 1994
K940025manan medical productsMANAN BONE MARROW HARVEST NEEDLESFebruary 25, 1994
K930158symbiosisBONE MARROW BIOPSY PROCEDURE TRAYJuly 2, 1993
K925621kirwan surgical productsIRRIGATION/ASPIRATION TUBING SETMay 7, 1993
K924501symbiosisGILLAM-TUKEL BONE MARROW BIOPSY NEEDLEApril 20, 1993
K925416symbiosisSYMBIOSIS BONE MARROW BIOPSY NEEDLEFebruary 23, 1993
K922614symbiosisTURKEL THORACENTESIS SYSTEMJuly 30, 1992
K915417medical device technologiesKOPAN'S TARGETJanuary 14, 1992
K914608dlpBREAST LES LOCAL WIRE ST. 48219/49220/48119/48120January 9, 1992
K913992northgate technologiesASPIRATION/INJECTION NEEDLEOctober 30, 1991
K912074manan medical productsBONE MARROW BIOPSY TRAYAugust 28, 1991