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FDA 510(k)

System 9 Sterile Battery Container

K-Number: K242834 · 2025-01-16

Decision Date2025-01-16
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

System 9 Sterile Battery Container is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2025-01-16 under approval number K242834. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the System 9 Sterile Battery Container?

System 9 Sterile Battery Container is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Stryker Instruments. The 510(k) number is K242834.

When was System 9 Sterile Battery Container approved by the FDA?

System 9 Sterile Battery Container received FDA 510(k) clearance on 2025-01-16, under approval number K242834.

What company makes System 9 Sterile Battery Container?

System 9 Sterile Battery Container is manufactured by Stryker Instruments.

What is the FDA product code for System 9 Sterile Battery Container?

The FDA product code for System 9 Sterile Battery Container is KCT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.