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

Device, Incontinence, Urosheath Type, Sterile

21 CFR 876.5250 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EXJ is the FDA product code for Device, Incontinence, Urosheath Type, Sterile, a class I device type, regulated under 21 CFR 876.5250. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EXJ
Device name
Device, Incontinence, Urosheath Type, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
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
22
Ingested recalls
0

Clearances, product code EXJ

By decision year
22 clearances under product code EXJ with a decision year between 1977 and 1997, 1995 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code EXJ by decision year
YearClearances
19771
19851
19912
19922
19931
19942
19956
19964
19973

Applicants with the most clearances

Product code EXJ
Applicants holding the most 510(k) clearances under product code EXJ
ApplicantClearances
Sierra Laboratories, Inc.5
MEDLINE INDUSTRIES, LP - Northfield3
Convatec, A Division of E.R. Squibb & Sons3
Hollister, Inc.2
Mentor2
Rochester Medical Corp.2
Advanced Care Medical Products1
Convatec, A Bristol-Myers Squibb Co.1
Dbt Medical, Ltd.1
General Polymers1

Companies listing this code with FDA

Companies whose registered establishments list this code