FDA 510(k) Applications for Medical Device Product Code "DWO"
(Needle, Biopsy, Cardiovascular)

FDA 510(k) Number Applicant Device Name Decision Date
K874585 ANGIOMED U.S., INC. ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE 12/02/1987
K853312 ARGON MEDICAL CORP. ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES 09/12/1985
K820269 CIVCO MEDICAL INSTRUMENTS CO., INC. RNG SERIES ULTRASOUND NEEDLE/CATH. GDS 03/23/1982
K872597 DIANON SYSTEMS, INC. FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE 07/28/1987
K913815 HART ENTERPRISES, INC. AUTOMATED BIOPSY DEVICE, MODIFICATION 10/30/1991
K885149 HART ENTERPRISES, INC. NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE 01/26/1989
K890925 MANAN MEDICAL PRODUCTS, INC. MANAN BONE MARROW BIOPSY NEEDLE 04/11/1989
K921418 MEDICAL DEVICE TECHNOLOGIES, INC. ULTRA-CORE BIOPSY NEEDLES 06/19/1992
K885145 MEDSURG INDUSTRIES, INC. MEDSURG GREENE NEEDLE 03/14/1989
K882013 OCEAN MEDICAL PRODUCTS, LTD. SOFT TISSUE BIOPSY DEVICE 06/15/1988
K933364 VLV ASSOCIATES, INC. PROMED BIOPSY NEEDLE 02/15/1994


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