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DWO — Needle, Biopsy, Cardiovascular Class I

FDA Device Classification

Classification Details

Product Code
DWO
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
K933364vlv associatesPROMED BIOPSY NEEDLEFebruary 15, 1994
K921418medical device technologiesULTRA-CORE BIOPSY NEEDLESJune 19, 1992
K913815hart enterprisesAUTOMATED BIOPSY DEVICE, MODIFICATIONOctober 30, 1991
K890925manan medical productsMANAN BONE MARROW BIOPSY NEEDLEApril 11, 1989
K885145medsurg industriesMEDSURG GREENE NEEDLEMarch 14, 1989
K885149hart enterprisesNEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEJanuary 26, 1989
K882013ocean medical productsSOFT TISSUE BIOPSY DEVICEJune 15, 1988
K874585angiomed u.sANGIOMED OSTY-CUT BONE BIOPSY NEEDLEDecember 2, 1987
K872597dianon systemsFINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATEJuly 28, 1987
K853312argon medicalARGON CUT BIOPSY NEEDLES, VARIOUS SIZESSeptember 12, 1985
K820269civco medical instruments coRNG SERIES ULTRASOUND NEEDLE/CATH. GDSMarch 23, 1982