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510(k) K943835

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID by Orion Life Systems, Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1995
Date Received
August 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Orion Life Systems, Inc.

  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)

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  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)