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

Blade, Scalpel

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

GES is the FDA product code for Blade, Scalpel, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
GES
Device name
Blade, 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
48
Ingested recalls
13

Clearances, product code GES

By decision year
48 clearances under product code GES with a decision year between 1976 and 2003, 1985 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GES by decision year
YearClearances
19764
19775
19781
19815
19821
19847
19859
19865
19872
19883
19901
19911
19921
19932
20031

Applicants with the most clearances

Product code GES
Applicants holding the most 510(k) clearances under product code GES
ApplicantClearances
Aeroceuticals4
Imm Enterprises, Ltd.3
Medelec Intl. Corp.3
American Safety Razor Co.2
Keisei Medical Industrial Co., Ltd.2
Lukens Corp.2
Abco Dealers, Inc.1
Ailee C/O Havel'S, Inc.1
An-Med Intl.1
Anapach Effort, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 279 companies shown, in name order