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510(k) K190367

Smith & Nephew Tablet Application by Smith & Nephew — Product Code QGY

K190367 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "Smith & Nephew Tablet Application". The FDA issued a decision of Substantially Equivalent on May 21, 2019. The device falls under product code QGY (Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera), 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
May 21, 2019
Date Received
February 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.

Other clearances by Smith & Nephew

  • 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)
  • K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail (December 9, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)

FDA data resources