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510(k) K914505

STONE BASKET by Surgitek Medical Engineering Corp. — Product Code FFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
October 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Surgitek Medical Engineering Corp.

  • K914504 — CYTOLOGY BRUSH (February 18, 1992)
  • K914495 — E.R.C.P. CATHETER (January 30, 1992)
  • K914497 — BIOPSY FORCEPS (January 3, 1992)
  • K914496 — SCLEROTHERAPY NEEDLE (December 5, 1991)
  • K914503 — GRASPING FORCEPS (December 5, 1991)
  • K913928 — SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT (November 19, 1991)
  • K913294 — SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (October 4, 1991)
  • K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (June 25, 1991)
  • K910768 — SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE (March 19, 1991)
  • K903127 — SURGITEK(R) TURP MONITOR (October 9, 1990)

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  • K172299 — Accordion Piccolo Stone Management Device (September 19, 2017)
  • K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (May 16, 2011)
  • K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (November 13, 2008)
  • K052048 — ACCORDION (September 13, 2005)
  • K012581 — REPROCESSED STONE RETRIEVAL BASKETS (February 14, 2002)
  • K972091 — AMS FOREIGN BODY EXTRATOR (August 29, 1997)
  • K970489 — COMEG ENDOSCOPY GRASPING FORCEPS (March 19, 1997)
  • K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (July 31, 1996)
  • K961248 — BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BA (May 28, 1996)