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FDA 510(k)

Percutaneous Introducer Needle

K-Number: K191295 · 2019-08-06

ApplicantProgressive Medical, Inc.
Decision Date2019-08-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Percutaneous Introducer Needle is a medical device manufactured by Progressive Medical, Inc.. It received FDA 510(k) clearance on 2019-08-06 under approval number K191295. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Percutaneous Introducer Needle?

Percutaneous Introducer Needle is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Progressive Medical, Inc.. The 510(k) number is K191295.

When was Percutaneous Introducer Needle approved by the FDA?

Percutaneous Introducer Needle received FDA 510(k) clearance on 2019-08-06, under approval number K191295.

What company makes Percutaneous Introducer Needle?

Percutaneous Introducer Needle is manufactured by Progressive Medical, Inc..

What is the FDA product code for Percutaneous Introducer Needle?

The FDA product code for Percutaneous Introducer Needle is GCJ.

Related Clinical Trials

NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT07325578 U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT05301959 Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy RECRUITING NCT07541235 The Ladera Suture-Mediated Large Bore Closure Pivotal Study NOT_YET_RECRUITING

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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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