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510(k) K970966

COMFORT CATH CHOICE MALE EXTERNAL CATHETER by Sierra Laboratories, Inc. — Product Code EXJ

K970966 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "COMFORT CATH CHOICE MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on April 22, 1997. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250. Sierra Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1997
Date Received
March 17, 1997
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 Sierra Laboratories, Inc.

  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER (April 19, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931156 — CONE CATH (July 1, 1993)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)
  • K873039 — MODEL 820 TOP=TRAK (February 11, 1988)
  • K832450 — URO-TEX MALE EXTERNAL CATHETER (October 14, 1983)
  • K811887 — SKIN STAPLE EXTRACTOR (July 27, 1981)

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)
  • 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)
  • K950690 — PROSYS URIHESICE SYSTEM NL (March 23, 1995)

FDA data resources