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510(k) K083598

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION by KARL STORZ Endoscopy-America, Inc. — Product Code ODA

K083598 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION". The FDA issued a decision of Substantially Equivalent on May 29, 2009. The device falls under product code ODA (Endoscopic Central Control Unit), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
December 5, 2008
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 Endoscopy-America, Inc.

  • K252624 — KARL STORZ Laryngoscopes and Accessories (May 15, 2026)
  • K223923 — HOPKINS Telescopes (March 30, 2023)
  • K202957 — Flexible Video Cysto-Urethroscope (C-view) (October 29, 2020)
  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
  • K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)

Other clearances for product code ODA

  • K232406 — KARL STORZ OR1™ SCB CONTROL (WU300) (October 3, 2023)
  • 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)
  • K080410 — KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (April 9, 2008)

FDA data resources