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FDA 510(k)

SteriTite Container System with MediTray Products

K-Number: K212711 · 2022-04-29

ApplicantCase Medical, Inc.
Decision Date2022-04-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriTite Container System with MediTray Products is a medical device manufactured by Case Medical, Inc.. It received FDA 510(k) clearance on 2022-04-29 under approval number K212711. 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 SteriTite Container System with MediTray Products?

SteriTite Container System with MediTray Products is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Case Medical, Inc.. The 510(k) number is K212711.

When was SteriTite Container System with MediTray Products approved by the FDA?

SteriTite Container System with MediTray Products received FDA 510(k) clearance on 2022-04-29, under approval number K212711.

What company makes SteriTite Container System with MediTray Products?

SteriTite Container System with MediTray Products is manufactured by Case Medical, Inc..

What is the FDA product code for SteriTite Container System with MediTray Products?

The FDA product code for SteriTite Container System with MediTray Products is KCT.

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Related PubMed Literature

PMID: 41895688 Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs). Journal of pharmaceutical sciences (2026) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Case Medical, Inc.

K161415SteriTite Containers System & MediTray Products K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories K221492SteriTite Container System with MediTray Parts

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, 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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