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FDA 510(k)

Sterilization Cassette (CASS-1)

K-Number: K262042 · 2026-10-14

ApplicantAlliedstar Medical Equipment Co., Ltd.
Decision Date2026-10-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Cassette (CASS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Alliedstar Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K262042. 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 Sterilization Cassette (CASS-1)?

Sterilization Cassette (CASS-1) is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is Alliedstar Medical Equipment Co., Ltd.. The 510(k) number is K262042.

When did Sterilization Cassette (CASS-1) receive FDA 510(k) clearance?

Sterilization Cassette (CASS-1) received FDA 510(k) clearance on 2026-10-14, under 510(k) number K262042.

Who is the listed applicant for Sterilization Cassette (CASS-1)?

The FDA 510(k) record lists Alliedstar Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Cassette (CASS-1)?

The FDA product code for Sterilization Cassette (CASS-1) is KCT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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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