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

Dilator, Urethral, Mechanical

21 CFR 876.5520 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAH is the FDA product code for Dilator, Urethral, Mechanical, a class II device type, regulated under 21 CFR 876.5520. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FAH
Device name
Dilator, Urethral, Mechanical
Regulation
21 CFR 876.5520
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
4
Ingested recalls
0

Clearances, product code FAH

By decision year
4 clearances under product code FAH with a decision year between 1983 and 1993, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FAH by decision year
YearClearances
19831
19902
19931

Applicants with the most clearances

Product code FAH
Applicants holding the most 510(k) clearances under product code FAH
ApplicantClearances
Boston Scientific Corporation2
Cook Incorporated1
Thomas J. Fogarty, M.D.1

Companies listing this code with FDA

Companies whose registered establishments list this code