Cleared Traditional

System 9 Sterile Battery Container

K242834 · Stryker Instruments · General Hospital

Jan 2025

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K242834 is an FDA 510(k) clearance for the System 9 Sterile Battery Container, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 16, 2025, 119 days after receiving the submission on September 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K242834 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	January 16, 2025
Days to Decision	119 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850