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510(k) K192876

INTELLIO Tablet Application by Smith & Nephew — Product Code ODA

K192876 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "INTELLIO Tablet Application". The FDA issued a decision of Substantially Equivalent on February 27, 2020. 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 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2020
Date Received
October 8, 2019
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

  • K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MI (July 9, 2026)
  • DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (July 6, 2026)
  • K254084 — AETOS Shoulder System - CONCELOC Glenoids (April 6, 2026)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPT (June 25, 2025)
  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • K250677 — LEGION Total Knee System (April 2, 2025)
  • K250571 — CATALYSTEM Femoral Stems (March 28, 2025)
  • K241666 — EVOS Pelvic and Acetabular System (February 19, 2025)

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)
  • 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