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FDA 510(k)

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

K-Number: K162721 · 2016-12-22

ApplicantAlliqua Biomedical, Inc.
Decision Date2016-12-22
Product CodeNRB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is a medical device manufactured by Alliqua Biomedical, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K162721. The device is classified under product code NRB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Alliqua Biomedical, Inc.. The 510(k) number is K162721.

When was Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator approved by the FDA?

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator received FDA 510(k) clearance on 2016-12-22, under approval number K162721.

What company makes Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is manufactured by Alliqua Biomedical, Inc..

What is the FDA product code for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

The FDA product code for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is NRB.

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Related PubMed Literature

PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021)

Other Devices by Alliqua Biomedical, Inc.

K171041SilverSeal

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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