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

System, Gastrointestinal Motility (Electrical)

21 CFR 876.1725 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFX is the FDA product code for System, Gastrointestinal Motility (Electrical), a class II device type, regulated under 21 CFR 876.1725. As of , FDA records hold 69 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FFX
Device name
System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
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
69
Ingested recalls
7

Clearances, product code FFX

By decision year
69 clearances under product code FFX with a decision year between 1976 and 2025, 1999 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code FFX by decision year
YearClearances
19761
19781
19811
19834
19883
19901
19911
19921
19931
19942
19961
19972
19982
19997
20001
20016
20022
20031
20041
20051
20061
20072
20081
20092
20102
20124
20131
20163
20172
20181
20194
20201
20233
20241
20251

Applicants with the most clearances

Product code FFX
Applicants holding the most 510(k) clearances under product code FFX
ApplicantClearances
Crospon, Ltd.7
Medtronic Functional Diagnostics A/S7
Diversatek Healthcare Inc7
Medical Measurement Systems B.V.5
Mui Scientific4
Anx Robotica Corp.2
Medtronic, Inc.2
Dentsleeve Pty., Ltd.2
G & J Electronics, Inc.2
Honeywell, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order