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
GCMClass II

Endoscope, Rigid

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

GCM is the FDA product code for Endoscope, Rigid, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GCM
Device name
Endoscope, Rigid
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
18
Ingested recalls
0

Clearances, product code GCM

By decision year
18 clearances under product code GCM with a decision year between 1985 and 2021, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GCM by decision year
YearClearances
19852
19891
19901
19921
19933
19952
19963
19992
20001
20091
20211

Applicants with the most clearances

Product code GCM
Applicants holding the most 510(k) clearances under product code GCM
ApplicantClearances
Karl Storz Endoscopy-America, Inc.2
Richard Wolf Medical Instruments Corp.2
American Edwards Laboratories1
Applied Medical Resources Corp1
Electro Fiberoptics Corp.1
Ethicon Endo-Surgery Inc1
Laser-Optik-Systeme GmbH & Co. KG1
Marlo Surgical Technology1
Medical Laser, Inc.1
Microvasive1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order