DWO · Class I · 21 CFR 878.4800

FDA Product Code DWO: Needle, Biopsy, Cardiovascular

Leading manufacturers include CIVCO Medical Instruments Co., Inc., Argon Medical Corp. and Angiomed U.S., Inc..

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 Jun 19, 1992
ULTRA-CORE BIOPSY NEEDLES
K921418
Medical Device Technologies, Inc.
General & Plastic Surgery · 87d
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 Dec 02, 1987
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
K874585
Angiomed U.S., Inc.
General & Plastic Surgery · 23d
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