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510(k) K942941

CONQUEST MALE CONTINENCE SYSTEM by Convatec, A Bristol-Myers Squibb Co. — Product Code EXJ

K942941 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "CONQUEST MALE CONTINENCE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 17, 1995. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1995
Date Received
June 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Convatec, A Bristol-Myers Squibb Co.

  • K032734 — CONVATEC FECAL MANAGEMENT SYSTEM (April 8, 2004)
  • K990368 — DUODERM HYDROACTIVE GEL WOUND DRESSING (March 26, 1999)
  • K982116 — AQUACEL HYDROFIBER WOUND DRESSING (September 8, 1998)
  • K973806 — DUODERM HYDROACTIVE GEL (December 29, 1997)
  • K973807 — DUODERM HYDROACTIVE PASTE (December 23, 1997)
  • K973716 — DUODERM EXTRA THIN CGF DRESSING (December 17, 1997)
  • K973717 — COMBIDERM ACD (December 17, 1997)
  • K954918 — COMBIDERM ACD (December 26, 1995)
  • K940895 — EPIVIEW (November 22, 1994)

Other clearances for product code EXJ

  • K970465 — BOUSER'S URINAL (December 18, 1997)
  • K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (July 31, 1997)
  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K963265 — PROSYS SAMEC LA (October 25, 1996)
  • K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER (September 16, 1996)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K945628 — CLEAR ADVANTAGE II (July 6, 1995)
  • K951530 — PROSYS URIHESIVE SYSTEM LA (May 12, 1995)

FDA data resources