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510(k) K930483

URETERAL CATHETER by Surgitek — Product Code EYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 16, 1993
Date Received
January 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 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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