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

Staple, Removable (Skin)

21 CFR 878.4760 / General, Plastic Surgery
FDA source (opens on fda.gov)

GDT is the FDA product code for Staple, Removable (Skin), a class I device type, regulated under 21 CFR 878.4760. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GDT
Device name
Staple, Removable (Skin)
Regulation
21 CFR 878.4760
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
19
Ingested recalls
5

Clearances, product code GDT

By decision year
19 clearances under product code GDT with a decision year between 1976 and 1996, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GDT by decision year
YearClearances
19761
19802
19822
19832
19841
19853
19861
19901
19912
19921
19931
19941
19961

Applicants with the most clearances

Product code GDT
Applicants holding the most 510(k) clearances under product code GDT
ApplicantClearances
Edward Weck, Inc.3
Ethicon, Inc2
Prosper, Inc.2
3M Company1
American V. Mueller1
Busse Hospital Disposables1
Continental Medical Laboratories, Inc.1
Cypress Medical Products LLC1
Davis & Geck, Inc.1
DeRoyal Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 89 companies shown, in name order