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FDA 510(k)

GENESIS REUSABLE RIGID CONTAINER SYSTEM

K-Number: K112535 · 2012-04-27

ApplicantCarefusion 2200, Inc.
Decision Date2012-04-27
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENESIS REUSABLE RIGID CONTAINER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K112535. 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 GENESIS REUSABLE RIGID CONTAINER SYSTEM?

GENESIS REUSABLE RIGID CONTAINER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K112535.

When did GENESIS REUSABLE RIGID CONTAINER SYSTEM receive FDA 510(k) clearance?

GENESIS REUSABLE RIGID CONTAINER SYSTEM received FDA 510(k) clearance on 2012-04-27, under 510(k) number K112535.

Who is the listed applicant for GENESIS REUSABLE RIGID CONTAINER SYSTEM?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS REUSABLE RIGID CONTAINER SYSTEM?

The FDA product code for GENESIS REUSABLE RIGID CONTAINER SYSTEM is KCT.

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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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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