510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GCQClass II

Endoscope, Flexible

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

GCQ is the FDA product code for Endoscope, Flexible, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
GCQ
Device name
Endoscope, Flexible
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
5
Ingested recalls
22

Clearances, product code GCQ

By decision year
5 clearances under product code GCQ with a decision year between 1986 and 1993, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GCQ by decision year
YearClearances
19861
19872
19901
19931

Applicants with the most clearances

Product code GCQ
Applicants holding the most 510(k) clearances under product code GCQ
ApplicantClearances
Cerenovus, Inc.2
Cooper Lasersonics, Inc.1
Medical Laser, Inc.1
Van-Tec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code