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FDA 510(k)

System 9 Sterile Battery Container

K-Number: K242834 · 2025-01-16

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

Device Summary

System 9 Sterile Battery Container is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-01-16 under 510(k) 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. The listed applicant is Stryker Instruments. The 510(k) number is K242834.

When did System 9 Sterile Battery Container receive FDA 510(k) clearance?

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

Who is the listed applicant for System 9 Sterile Battery Container?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

Official Source

View on FDA Database →

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

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