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
FIEClass II

Needle, Fistula

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FIE is the FDA product code for Needle, Fistula, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 80 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FIE
Device name
Needle, Fistula
Regulation
21 CFR 876.5540
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
80
Ingested recalls
7

Clearances, product code FIE

By decision year
80 clearances under product code FIE with a decision year between 1977 and 2026, 1977 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code FIE by decision year
YearClearances
19779
19781
19793
19804
19812
19831
19852
19866
19881
19891
19902
19913
19921
19931
19941
19951
19961
19971
19981
19995
20005
20013
20021
20031
20041
20051
20061
20073
20091
20103
20113
20121
20142
20152
20171
20181
20221
20251
20261

Applicants with the most clearances

Product code FIE
Applicants holding the most 510(k) clearances under product code FIE
ApplicantClearances
JMS Co., Ltd.11
JMS North America Corp.10
Medisystems Corp.6
Nipro Medical Corporation6
Sorensen Research6
Hospal Medical Corp.4
Bain Medical Equipment(guangzhou) Co., Ltd.2
Terumo America, Inc.2
Togo Medikit Co., Ltd.2
Amisco Trading Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order