Atlas FDA

EXJ

22 FDA 510(k) clearances · Product code

62 daysmedian time to decision
232 days90th percentile
22clearances measured

FDA profile

Official device name
Device, Incontinence, Urosheath Type, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 876.5250
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2002: 1 · 2003: 4 · 2004: 1 · 2007: 2 · 2011: 5 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BOUSER'S URINAL (K970465)General Polymers1997-12-18
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (K972100)Advanced Care Medical Products1997-07-31
COMFORT CATH CHOICE MALE EXTERNAL CATHETER (K970966)Sierra Laboratories, Inc.1997-04-22
PROSYS SAMEC LA (K963265)Convatec, A Division of E.R. Squibb & Sons1996-10-25
SELF RETAINING MALE EXTERNAL URINARY CATHETER (K962900)Hollister, Inc.1996-09-16
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (K962384)Sierra Laboratories, Inc.1996-07-15
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (K962413)Sierra Laboratories, Inc.1996-07-15
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (K952082)Rochester Medical Corp.1995-07-18
CLEAR ADVANTAGE II (K945628)Mentor Corp.1995-07-06
PROSYS URIHESIVE SYSTEM LA (K951530)Convatec, A Division of E.R. Squibb & Sons1995-05-12
PROSYS URIHESICE SYSTEM NL (K950690)Convatec, A Division of E.R. Squibb & Sons1995-03-23
CONQUEST MALE CONTINENCE SYSTEM (K942941)Convatec, A Bristol-Myers Squibb Co.1995-03-17
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER (K946243)Coloplast A/S1995-02-13
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER (K940269)Hollister, Inc.1994-06-02
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER (K934266)Sierra Laboratories, Inc.1994-04-19
CONE CATH (K931156)Sierra Laboratories, Inc.1993-07-01
MALE EXTERNAL CATHETER (K923136)Rochester Medical Corp.1992-12-03
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH (K924407)Coloplast A/S1992-09-23
SILICONE MALE EXTERNAL CATHETER (K913524)Mentor Corp.1991-10-04
CONDOM SEAL (K903715)Mark Sullivan, M.D., P.C.1991-01-23
SAFESEAL REUSABLE URINAL SYSTEM (K851682)Dbt Medical , Ltd.1985-06-24
CATHETER, DISP., EXTERNAL, MALE (K772144)Medline Industries, Inc.1977-11-28

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Every clearance here is in the API, with alerts when new ones post.