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510(k) K965176

PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS by Pilling Weck Group — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1997
Date Received
December 24, 1996
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 Pilling Weck Group

  • K971334 — PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR (June 11, 1997)
  • K964450 — SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT (January 10, 1997)
  • K964123 — REUSABLE TROCAR WITH SLEEVE (COMMON) (December 12, 1996)
  • K963815 — REUSABLE TROCAR WITH SLEEVE (COMMON) (November 5, 1996)

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)