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510(k) K946296

QUADRA-COIL URETERAL STENT by Surgitek — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
December 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Surgitek

  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • 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)
  • K926344 — HYDROPHILIC COATED GUIDEWIRE (March 5, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)
  • K922542 — GRASPING FORCEPS (August 19, 1992)

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  • K213186 — NovoFlow Reinforced Ureteral Stent (February 16, 2022)