DWO · Class I · 21 CFR 878.4800

FDA Product Code DWO: Needle, Biopsy, Cardiovascular

Leading manufacturers include Hart Enterprises, Inc., CIVCO Medical Instruments Co., Inc. and Argon Medical Corp..

11
Total
11
Cleared
65d
Avg days
1982
Since

FDA 510(k) Cleared Needle, Biopsy, Cardiovascular Devices (Product Code DWO)

11 devices
1–11 of 11
Cleared Feb 15, 1994
PROMED BIOPSY NEEDLE
K933364
Vlv Associates, Inc.
General & Plastic Surgery · 221d
Cleared Jun 19, 1992
ULTRA-CORE BIOPSY NEEDLES
K921418
Medical Device Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Oct 30, 1991
AUTOMATED BIOPSY DEVICE, MODIFICATION
K913815
Hart Enterprises, Inc.
General & Plastic Surgery · 65d
Cleared Apr 11, 1989
MANAN BONE MARROW BIOPSY NEEDLE
K890925
Manan Medical Products, Inc.
General & Plastic Surgery · 46d
Cleared Mar 14, 1989
MEDSURG GREENE NEEDLE
K885145
Medsurg Industries, Inc.
General & Plastic Surgery · 89d
Cleared Jan 26, 1989
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
K885149
Hart Enterprises, Inc.
General & Plastic Surgery · 42d
Cleared Jun 15, 1988
SOFT TISSUE BIOPSY DEVICE
K882013
Ocean Medical Products, Ltd.
General & Plastic Surgery · 33d
Cleared Dec 02, 1987
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
K874585
Angiomed U.S., Inc.
General & Plastic Surgery · 23d
Cleared Jul 28, 1987
FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
K872597
Dianon Systems, Inc.
General & Plastic Surgery · 26d
Cleared Sep 12, 1985
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
K853312
Argon Medical Corp.
General & Plastic Surgery · 36d
Cleared Mar 23, 1982
RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
K820269
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 49d

About Product Code DWO - Regulatory Context