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FDA 510(k)

SteriTite Container System with MediTray Parts

K-Number: K221492 · 2022-10-07

ApplicantCase Medical, Inc.
Decision Date2022-10-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriTite Container System with MediTray Parts 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 2022-10-07 under 510(k) number K221492. 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 Parts?

SteriTite Container System with MediTray Parts is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Case Medical, Inc.. The 510(k) number is K221492.

When did SteriTite Container System with MediTray Parts receive FDA 510(k) clearance?

SteriTite Container System with MediTray Parts received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221492.

Who is the listed applicant for SteriTite Container System with MediTray Parts?

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 SteriTite Container System with MediTray Parts?

The FDA product code for SteriTite Container System with MediTray Parts 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.

K252854SteriTite Container System with MediTray ProductsK240898SteriTite rigid reusable sterilization container with MediTray ProductsK212711SteriTite Container System with MediTray ProductsK173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessoriesK161415SteriTite Containers System & MediTray Products

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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