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

Device, Cystometric, Hydraulic

21 CFR 876.1620 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FEN is the FDA product code for Device, Cystometric, Hydraulic, a class II device type, regulated under 21 CFR 876.1620. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FEN
Device name
Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
3

Clearances, product code FEN

By decision year
36 clearances under product code FEN with a decision year between 1991 and 2021, 1995 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code FEN by decision year
YearClearances
19913
19937
19943
199511
19963
19973
19981
20002
20082
20211

Applicants with the most clearances

Product code FEN
Applicants holding the most 510(k) clearances under product code FEN
ApplicantClearances
Fiberoptic Sensor Technlogies, Inc.8
Life-Tech Intl., Inc.5
Abbott Medical3
Greatbatch Medical3
Rusch Intl.2
Andromeda Medizinische Systeme GmbH1
C.R. Bard Inc1
Circon Video1
Cook Incorporated1
Dantec Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order