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510(k) K926344

HYDROPHILIC COATED GUIDEWIRE by Surgitek — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1993
Date Received
December 17, 1992
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

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  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)
  • K922542 — GRASPING FORCEPS (August 19, 1992)

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  • 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)