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FDA 510(k)

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

K-Number: K151072 · 2016-01-22

ApplicantSolo-Dex, Inc.
Decision Date2016-01-22
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a medical device manufactured by Solo-Dex, Inc.. It received FDA 510(k) clearance on 2016-01-22 under approval number K151072. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Solo-Dex, Inc.. The 510(k) number is K151072.

When was Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit approved by the FDA?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit received FDA 510(k) clearance on 2016-01-22, under approval number K151072.

What company makes Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is manufactured by Solo-Dex, Inc..

What is the FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

The FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is BSP.

Related Clinical Trials

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Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025)

Related Devices (Code: BSP)

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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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