Cleared Special

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices (K201244) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201244 · Transmed7, LLC · Gastroenterology & Urology device
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Aug 2020
Decision
91d
Days
Class 2
Risk

K201244 is an FDA 510(k) clearance for the Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Transmed7, LLC (Portola Valley, US). The FDA issued a Cleared decision on August 7, 2020 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Transmed7, LLC devices

Submission Details

510(k) Number K201244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2020
Decision Date August 07, 2020
Days to Decision 91 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 360
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