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510(k) K901000

URO TEX URINALS by Sierra Laboratories, Inc. — Product Code EYZ

K901000 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "URO TEX URINALS". The FDA issued a decision of Substantially Equivalent on March 26, 1990. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, 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
March 26, 1990
Date Received
March 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Sierra Laboratories, Inc.

  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING 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)
  • 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 EYZ

  • K964219 — ZIP CONDOM CATHETER (August 11, 1997)
  • K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10 (November 19, 1996)
  • K952780 — URINARY GEL DRAINAGE SYSTEM (December 12, 1995)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAG (May 14, 1993)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)

FDA data resources