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510(k) K242923

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) by Envision Endoscopy — Product Code OCZ

K242923 is an FDA 510(k) premarket notification submitted by Envision Endoscopy for the device "SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Envision Endoscopy has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
September 24, 2024
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 Envision Endoscopy

  • K243750 — SimpleStitch Suturing System (April 17, 2025)

Other clearances for product code OCZ

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

FDA data resources