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

Stent, Ureteral

21 CFR 876.4620 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAD is the FDA product code for Stent, Ureteral, a class II device type, regulated under 21 CFR 876.4620. As of , FDA records hold 122 510(k) clearances under this code, the most recent dated , and 55 recalls.

Classification record

Product code
FAD
Device name
Stent, Ureteral
Regulation
21 CFR 876.4620
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
122
Ingested recalls
55

Clearances, product code FAD

By decision year
122 clearances under product code FAD with a decision year between 1978 and 2026, 2018 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code FAD by decision year
YearClearances
19781
19801
19821
19835
19843
19854
19867
19876
19886
19891
19917
19922
19934
19943
19951
19964
19986
19993
20012
20024
20033
20043
20061
20071
20081
20101
20141
20164
20178
20189
20195
20201
20212
20225
20241
20254
20261

Applicants with the most clearances

Product code FAD
Applicants holding the most 510(k) clearances under product code FAD
ApplicantClearances
Cook Incorporated18
Boston Scientific Corporation12
Surgitek9
Mentor8
C.R. Bard Inc7
MEDLINE INDUSTRIES, LP - Northfield7
Applied Medical Resources Corp5
Medical Engineering Corp.5
Q Urological Corporation3
Urosurge, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order