K254014

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

510(k) number
K254014
Device name
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Applicant
Stryker Endoscopy CA · US
Product code
GCJ — Laparoscope, General & Plastic Surgery
Decision date
2026-01-13
Date received
2025-12-15
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Gastroenterology, Urology
510(k) Summary (official FDA PDF): K254014.pdf
Official FDA record: K254014
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.