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

Endoscope, Mirror

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

GCO is the FDA product code for Endoscope, Mirror, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GCO
Device name
Endoscope, Mirror
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
3
Ingested recalls
0

Clearances, product code GCO

By decision year
3 clearances under product code GCO with a decision year between 1979 and 1986, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GCO by decision year
YearClearances
19791
19862

Applicants with the most clearances

Product code GCO
Applicants holding the most 510(k) clearances under product code GCO
ApplicantClearances
Cytotech, Inc.1
Johnson & Johnson Professionals, Inc.1
Simpson/Basye, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GCO.