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

Endoscope, Ac-Powered And Accessories

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GCP is the FDA product code for Endoscope, Ac-Powered And Accessories, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GCP
Device name
Endoscope, Ac-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
5

Clearances, product code GCP

By decision year
13 clearances under product code GCP with a decision year between 1977 and 1996, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GCP by decision year
YearClearances
19773
19791
19801
19821
19841
19851
19862
19891
19901
19961

Applicants with the most clearances

Product code GCP
Applicants holding the most 510(k) clearances under product code GCP
ApplicantClearances
Propper Mfg Co Inc3
American Endoscopy, Inc.1
Endotherapeutics1
Endovations1
Medical Dynamics, Inc.1
North Eos Industries, Inc.1
Olympus Corp.1
Porges Corp.1
Reichert Scientific Instruments1
Retech1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order