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
FCXClass II

Insufflator, Automatic Carbon-Dioxide For Endoscope

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

FCX is the FDA product code for Insufflator, Automatic Carbon-Dioxide For Endoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FCX
Device name
Insufflator, Automatic Carbon-Dioxide For Endoscope
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
Yes
Ingested clearances
25
Ingested recalls
2

Clearances, product code FCX

By decision year
25 clearances under product code FCX with a decision year between 1985 and 2026, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCX by decision year
YearClearances
19851
19881
19911
19932
19942
20021
20031
20051
20071
20091
20111
20121
20131
20142
20161
20181
20191
20201
20211
20231
20241
20261

Applicants with the most clearances

Product code FCX
Applicants holding the most 510(k) clearances under product code FCX
ApplicantClearances
E-Z-EM, Inc4
Bracco Diagnostic, Inc.3
Palliare2
Baronova, Inc.1
Byrne Medical, Inc.1
FUJIFILM Corporation1
FUJIFILM Healthcare Americas Corporation1
Ide Vision, Ltd.1
Jayco Pharmaceuticals1
Karl Storz Endoscopy-America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order