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EXJ — Device, Incontinence, Urosheath Type, Sterile Class I

FDA Device Classification

Classification Details

Product Code
EXJ
Device Class
Class I
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970465general polymersBOUSER'S URINALDecember 18, 1997
K972100advanced care medical productsVENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)July 31, 1997
K970966sierra laboratoriesCOMFORT CATH CHOICE MALE EXTERNAL CATHETERApril 22, 1997
K963265convatec, a division of e.r. squibb and sonsPROSYS SAMEC LAOctober 25, 1996
K962900hollisterSELF RETAINING MALE EXTERNAL URINARY CATHETERSeptember 16, 1996
K962413sierra laboratoriesCOMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERJuly 15, 1996
K962384sierra laboratoriesCOMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERJuly 15, 1996
K952082rochester medicalROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETERJuly 18, 1995
K945628mentorCLEAR ADVANTAGE IIJuly 6, 1995
K951530convatec, a division of e.r. squibb and sonsPROSYS URIHESIVE SYSTEM LAMay 12, 1995
K950690convatec, a division of e.r. squibb and sonsPROSYS URIHESICE SYSTEM NLMarch 23, 1995
K942941convatec, a bristol-myers squibbCONQUEST MALE CONTINENCE SYSTEMMarch 17, 1995
K946243coloplastCONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETERFebruary 13, 1995
K940269hollisterHOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETERJune 2, 1994
K934266sierra laboratoriesCOMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERApril 19, 1994
K931156sierra laboratoriesCONE CATHJuly 1, 1993
K923136rochester medicalMALE EXTERNAL CATHETERDecember 3, 1992
K924407coloplastCONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATHSeptember 23, 1992
K913524mentorSILICONE MALE EXTERNAL CATHETEROctober 4, 1991
K903715mark sullivan, m.d., p.cCONDOM SEALJanuary 23, 1991