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510(k) K934052

ALPINE REUSABLE LEG BAGS by Sierra Laboratories, Inc. — Product Code FAQ

K934052 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "ALPINE REUSABLE LEG BAGS". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, 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
January 7, 1994
Date Received
August 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, 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)
  • 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)
  • 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 FAQ

  • K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZ (July 18, 1996)
  • K960217 — CPR URINE BAG (March 28, 1996)
  • K955609 — CONVEEN URINE BAG - STERILE (December 29, 1995)
  • K953767 — PROSYS BEDSIDE DRAINAGE BAG (December 20, 1995)
  • K953783 — CONVEEN LEG BAG STRAP (September 13, 1995)
  • K951945 — PROSYS LEG BAG (May 25, 1995)
  • K945204 — URINE COLLECTOR & ACCESSORIES (November 2, 1994)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)
  • K924406 — CONVEEN(R) LEG BAG(500 ML) (October 30, 1992)

FDA data resources