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510(k) K232406

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

K232406 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ OR1™ SCB CONTROL (WU300)". The FDA issued a decision of Substantially Equivalent on October 3, 2023. The device falls under product code ODA (Endoscopic Central Control Unit), 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
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

  • K261102 — UNIDRIVE Select System (September 18, 2026)
  • K260884 — UNIDRIVE Select System (September 1, 2026)
  • K254103 — HOPKINS Telescopes for Arthroscopy (August 26, 2026)
  • K260209 — ENDOFLATOR+; Smart Smoke Evacuation (August 19, 2026)
  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K252800 — KARL STORZ Endoscopic Accessories for Urology (June 3, 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)

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)

FDA data resources