System 9 Sterile Battery Container— 510(k) K242834

Name: FDA 510(k) clearance K242834
Creator: U.S. Food and Drug Administration
Published: 2025-01-16

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K242834 for System 9 Sterile Battery Container, Substantially Equivalent on 2025-01-16. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Applicant: Stryker Instruments
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2024-09-19
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.