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

Blade, Saw, Surgical, Cardiovascular

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

DWH is the FDA product code for Blade, Saw, Surgical, Cardiovascular, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DWH
Device name
Blade, Saw, Surgical, Cardiovascular
Regulation
21 CFR 878.4820
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
4
Ingested recalls
1

Clearances, product code DWH

By decision year
4 clearances under product code DWH with a decision year between 1983 and 1990, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DWH by decision year
YearClearances
19831
19851
19861
19901

Applicants with the most clearances

Product code DWH
Applicants holding the most 510(k) clearances under product code DWH
ApplicantClearances
Cerenovus, Inc.1
Hall Surgical, Division of Zimmer, Inc.1
Micro-Aire Surgical Instruments, Inc.1
Temp Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order