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510(k) K221929

Smith+Nephew INTELLIO Tablet by Smith+Nephew — Product Code ODA

K221929 is an FDA 510(k) premarket notification submitted by Smith+Nephew for the device "Smith+Nephew INTELLIO Tablet". The FDA issued a decision of Substantially Equivalent on September 6, 2022. The device falls under product code ODA (Endoscopic Central Control Unit), a Class II device regulated under 21 CFR 876.1500. Smith+Nephew has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2022
Date Received
July 1, 2022
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 Smith+Nephew

  • K222653 — JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (October 28, 2022)

Other clearances for product code ODA

  • K232406 — KARL STORZ OR1™ SCB CONTROL (WU300) (October 3, 2023)
  • 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