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510(k) K252800

KARL STORZ Endoscopic Accessories for Urology by Karl Storz SE & CO. KG — Product Code OCZ

K252800 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ Endoscopic Accessories for Urology". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2026
Date Received
September 3, 2025
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 Karl Storz SE & CO. KG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K254228 — KARL STORZ Trocars with Valve Seals (May 11, 2026)
  • K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
  • K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens (February 26, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (February 12, 2026)
  • K251731 — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (December 5, 2025)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K253411 — Miniature Telescope for Urology (27033AA) (November 18, 2025)
  • K250388 — ENDOFLATOR + (September 22, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)

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)

FDA data resources