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FDA 510(k)

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

K-Number: K173259 · 2018-06-13

Decision Date2018-06-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) 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. The listed applicant is Case Medical, Inc.. The 510(k) number is K173259.

When did Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

The FDA 510(k) record lists Case Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Case Medical, Inc. as applicant

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.

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.

Official Source

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