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

Urethrotome

21 CFR 876.4770 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZO is the FDA product code for Urethrotome, a class II device type, regulated under 21 CFR 876.4770. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EZO
Device name
Urethrotome
Regulation
21 CFR 876.4770
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
5
Ingested recalls
1

Clearances, product code EZO

By decision year
5 clearances under product code EZO with a decision year between 1992 and 2000, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EZO by decision year
YearClearances
19921
19941
19951
19961
20001

Applicants with the most clearances

Product code EZO
Applicants holding the most 510(k) clearances under product code EZO
ApplicantClearances
Karl Storz Endoscopy-America, Inc.2
OLYMPUS Corporation of the Americas1
Olympus Corp.1
Richard Wolf Medical Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order