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FDA 510(k)

SteriTite Containers System & MediTray Products

K-Number: K161415 · 2017-02-10

ApplicantCase Medical, Inc.
Decision Date2017-02-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriTite Containers System & MediTray Products is a medical device manufactured by Case Medical, Inc.. It received FDA 510(k) clearance on 2017-02-10 under approval number K161415. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SteriTite Containers System & MediTray Products?

SteriTite Containers System & MediTray Products is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Case Medical, Inc.. The 510(k) number is K161415.

When was SteriTite Containers System & MediTray Products approved by the FDA?

SteriTite Containers System & MediTray Products received FDA 510(k) clearance on 2017-02-10, under approval number K161415.

What company makes SteriTite Containers System & MediTray Products?

SteriTite Containers System & MediTray Products is manufactured by Case Medical, Inc..

What is the FDA product code for SteriTite Containers System & MediTray Products?

The FDA product code for SteriTite Containers System & MediTray Products is FRG.

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Related PubMed Literature

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.

K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories K221492SteriTite Container System with MediTray Parts K212711SteriTite Container System with MediTray Products

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, 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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