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510(k) K913524

SILICONE MALE EXTERNAL CATHETER by Mentor Corp. — Product Code EXJ

K913524 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "SILICONE MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on October 4, 1991. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1991
Date Received
August 8, 1991
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 Mentor Corp.

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  • K053414 — MENTOR NOVASILK MESH (December 27, 2005)
  • K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (June 3, 2005)
  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)

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)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K962384 — COMFORT SHEATH REUSABLE 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