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510(k) K914503

GRASPING FORCEPS by Surgitek Medical Engineering Corp. — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1991
Date Received
October 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

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)
  • K914505 — STONE BASKET (December 9, 1991)
  • K914496 — SCLEROTHERAPY NEEDLE (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)

Other clearances for product code OCZ

  • K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cut (December 20, 2024)
  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K152802 — Grasping Forceps (January 21, 2016)
  • K150939 — Ensizor Endoscopic Scissors (June 8, 2015)
  • K141058 — ENSIZOR ENDOSCOPIC SCISSORS (August 1, 2014)
  • K133736 — ENDOSCOPIC SUTURE CUTTER (January 7, 2014)
  • K120084 — ENDOSCOPIC RETRIEVAL DEVICE (May 30, 2012)
  • K103688 — G-PROX EZ ENDOSCOPIC GRASPER (January 14, 2011)
  • K101298 — ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE (August 5, 2010)
  • K072684 — MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (January 4, 2008)