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

Dilator, Urethral

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

KOE is the FDA product code for Dilator, Urethral, a class II device type, regulated under 21 CFR 876.5520. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KOE
Device name
Dilator, Urethral
Regulation
21 CFR 876.5520
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
27
Ingested recalls
3

Clearances, product code KOE

By decision year
27 clearances under product code KOE with a decision year between 1979 and 2020, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KOE by decision year
YearClearances
19792
19802
19812
19842
19851
19872
19892
19904
19911
19923
19931
19962
19971
20041
20201

Applicants with the most clearances

Product code KOE
Applicants holding the most 510(k) clearances under product code KOE
ApplicantClearances
American Medical Systems, Inc.4
Vance Products, Inc.4
Advanced Surgical Intervention, Inc.2
Atrion Medical Products, Inc.2
Cook Incorporated2
G.D. Searle and Co.2
Van-Tec, Inc.2
American Edwards Laboratories1
Boston Scientific Corporation1
Imm Enterprises, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order