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

Brush, Scrub, Operating-Room

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

GEC is the FDA product code for Brush, Scrub, Operating-Room, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GEC
Device name
Brush, Scrub, Operating-Room
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
37
Ingested recalls
0

Clearances, product code GEC

By decision year
37 clearances under product code GEC with a decision year between 1979 and 1997, 1979 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code GEC by decision year
YearClearances
197911
19801
19813
19825
19834
19842
19851
19873
19883
19891
19901
19961
19971

Applicants with the most clearances

Product code GEC
Applicants holding the most 510(k) clearances under product code GEC
ApplicantClearances
Dexide, Inc.10
Absorbent Cotton Co., Inc.2
Ballard Medical Products2
H & P Industries, Inc.2
Acme United Corp.1
American Medical Disposable, Inc.1
American Pharmaseal Div. Ahsc1
American Sterilizer Co.1
Anago, Inc.1
Bio-Dyne, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order