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FDA 510(k)

Theracor

K-Number: K253339 · 2025-12-22

ApplicantStimlabs, LLC
Decision Date2025-12-22
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Theracor is a medical device manufactured by Stimlabs, LLC. It received FDA 510(k) clearance on 2025-12-22 under approval number K253339. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Theracor?

Theracor is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Stimlabs, LLC. The 510(k) number is K253339.

When was Theracor approved by the FDA?

Theracor received FDA 510(k) clearance on 2025-12-22, under approval number K253339.

What company makes Theracor?

Theracor is manufactured by Stimlabs, LLC.

What is the FDA product code for Theracor?

The FDA product code for Theracor is KGN.

Other Devices by Stimlabs, LLC

K242828Corplex P/ Theracor P/ Allacor P K231325Corplex P / Theracor P / Allacor P

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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