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

Handle, Scalpel

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

GDZ is the FDA product code for Handle, Scalpel, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
GDZ
Device name
Handle, Scalpel
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
16
Ingested recalls
13

Clearances, product code GDZ

By decision year
16 clearances under product code GDZ with a decision year between 1976 and 2009, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GDZ by decision year
YearClearances
19761
19814
19855
19863
19881
19891
20091

Applicants with the most clearances

Product code GDZ
Applicants holding the most 510(k) clearances under product code GDZ
ApplicantClearances
The Huxley Instrument Corp.2
Artiberia1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Brimfield Scientific Instruments1
Instrument Makar, Inc.1
Keisei Medical Industrial Co., Ltd.1
Kinetic Medical Products1
M-W Laboratories, Inc.1
Medelec Intl. Corp.1
Parke-Davis Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 423 companies shown, in name order