510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DWOClass I

Needle, Biopsy, Cardiovascular

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

DWO is the FDA product code for Needle, Biopsy, Cardiovascular, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
DWO
Device name
Needle, Biopsy, Cardiovascular
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
9

Clearances, product code DWO

By decision year
11 clearances under product code DWO with a decision year between 1982 and 1994, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DWO by decision year
YearClearances
19821
19851
19872
19881
19893
19911
19921
19941

Applicants with the most clearances

Product code DWO
Applicants holding the most 510(k) clearances under product code DWO
ApplicantClearances
Hart Enterprises, Inc.2
Angiomed U.S., Inc.1
Argon Medical Corp.1
CIVCO Medical Instruments Co., Inc.1
Dianon Systems, Inc.1
Argon Medical Devices, Inc1
Medical Device Technologies, Inc.1
Medsurg Industries, Inc.1
Ocean Medical Products, Ltd.1
VLV Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order