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510(k) K901219

EXTERNAL LEG BAG by Orion Life Systems, Inc. — Product Code FAQ

K901219 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "EXTERNAL LEG BAG". The FDA issued a decision of Substantially Equivalent on June 27, 1990. 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. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1990
Date Received
March 13, 1990
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 Orion Life Systems, Inc.

  • K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (January 24, 1995)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

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)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)

FDA data resources