510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191435Substantially Equivalent

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

Nalu Medical, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191435 is the FDA 510(k) clearance record for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4, a class II device, cleared for Nalu Medical, Inc. on under FDA product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)). FDA records list one 510(k) clearance for Nalu Medical, Inc. As of , FDA records show no recalls naming K191435.

Clearance record

Decision date
Received
(99 days to decision)
Product code
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Applicant
Nalu Medical, Inc. 2320 Faraday Ave., Suite 100, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZF

Trailing 12 months
1 clearance under product code GZF in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260