Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K-Number: K201244 · 2020-08-07
ApplicantTransmed7, LLC
Decision Date2020-08-07
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device manufactured by Transmed7, LLC. It received FDA 510(k) clearance on 2020-08-07 under approval number K201244. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Transmed7, LLC. The 510(k) number is K201244.
When was Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices approved by the FDA?
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance on 2020-08-07, under approval number K201244.
What company makes Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is manufactured by Transmed7, LLC.
What is the FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?
The FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is KNW.
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Official Source
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