IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4— 510(k) K191435

Name: FDA 510(k) clearance K191435
Creator: U.S. Food and Drug Administration
Published: 2019-09-06

Substantially Equivalent

Nalu Medical, Inc.

FDA 510(k) clearance K191435 for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4, Substantially Equivalent on 2019-09-06. Applicant: Nalu Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nalu Medical, Inc.
Product code: Code GZF
Device class: Class 2
Regulation: 21 CFR 882.5870
Advisory panel: Neurology
Date received: 2019-05-30
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.