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FDA 510(k)

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

K-Number: K191435 · 2019-09-06

ApplicantNalu Medical, Inc.
Decision Date2019-09-06
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is the device name listed in this FDA 510(k) record. The listed applicant is Nalu Medical, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191435. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Nalu Medical, Inc.. The 510(k) number is K191435.

When did IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 receive FDA 510(k) clearance?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191435.

Who is the listed applicant for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

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

What is the FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

The FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is GZF.

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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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