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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 the device name listed in this FDA 510(k) record. The listed applicant is Progressive Medical, Inc.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) 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. The listed applicant is Progressive Medical, Inc.. The 510(k) number is K191295.

When did Percutaneous Introducer Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Percutaneous Introducer Needle?

The FDA 510(k) record lists Progressive Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Percutaneous Introducer Needle?

The FDA product code for Percutaneous Introducer Needle is GCJ.

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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