Home / 510(k) Clearances / K232406

510(k) K232406

KARL STORZ OR1™ SCB CONTROL (WU300) by Karl Storz SE & CO. KG — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2023
Date Received
August 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Other clearances by Karl Storz SE & CO. KG

  • 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)
  • K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (June 6, 2025)
  • K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fibersc (May 2, 2025)

Other clearances for product code ODA

  • K221929 — Smith+Nephew INTELLIO Tablet (September 6, 2022)
  • K203566 — Tablet Application (May 13, 2021)
  • K192876 — INTELLIO Tablet Application (February 27, 2020)
  • K153205 — IDSS ForceTriad Control Module (August 1, 2016)
  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K111165 — KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE (January 6, 2012)
  • K102763 — SYSTEMS INTEGRATION (February 15, 2011)
  • K100345 — SYSTEMS INTEGRATION MODEL: ENDOALPHA (March 22, 2010)
  • K083598 — KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (May 29, 2009)
  • K080410 — KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (April 9, 2008)