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FDA 510(k)

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

K-Number: K173259 · 2018-06-13

ApplicantCase Medical, Inc.
Decision Date2018-06-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is a medical device manufactured by Case Medical, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K173259. 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 Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Case Medical, Inc.. The 510(k) number is K173259.

When was Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories approved by the FDA?

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories received FDA 510(k) clearance on 2018-06-13, under approval number K173259.

What company makes Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is manufactured by Case Medical, Inc..

What is the FDA product code for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

The FDA product code for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is KCT.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Case Medical, Inc.

K161415SteriTite Containers System & MediTray Products K221492SteriTite Container System with MediTray Parts K212711SteriTite Container System with MediTray Products

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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