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510(k) K103688

G-PROX EZ ENDOSCOPIC GRASPER by Usgi Medical — Product Code OCZ

K103688 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "G-PROX EZ ENDOSCOPIC GRASPER". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Usgi Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
December 17, 2010
Clearance Type
Special
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 Usgi Medical

  • K102931 — G-CINCH SUTURE GRASPER (December 30, 2010)
  • K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER (October 20, 2010)
  • K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 (February 17, 2010)
  • K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 205333 (October 7, 2009)
  • K072405 — USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (September 13, 2007)
  • K061276 — G-PROX ENDOSCOPIC GRASPER (December 6, 2006)
  • K061268 — G-LIX TISSUE GRASPER (July 31, 2006)
  • K061216 — USGI TRANSPORT ENDOSCOPIC GUIDE (May 15, 2006)
  • K051919 — MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE (July 26, 2005)
  • K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE (February 28, 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)
  • 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)

FDA data resources