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510(k) K051276

HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM by Richard Wolf Medical Instruments Corp. — Product Code OCZ

K051276 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 2005. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2005
Date Received
May 17, 2005
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 Richard Wolf Medical Instruments Corp.

  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (April 3, 2013)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR (August 3, 2012)
  • K090776 — MEGAPULSE LASER SYSTEM AND FIBERS (June 2, 2009)
  • K080617 — POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (June 27, 2008)
  • K080977 — 3 CCD ENDOCAM 5550 (May 14, 2008)
  • K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (July 19, 2007)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K051176 — FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 (October 5, 2005)

Other clearances for product code OCZ

  • K252800 — KARL STORZ Endoscopic Accessories for Urology (June 3, 2026)
  • 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)

FDA data resources