510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183579Substantially Equivalent

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

Boston Scientific Neuromodulation Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183579 is the FDA 510(k) clearance record for Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits, a class II device, cleared for Boston Scientific Neuromodulation on under FDA product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)). FDA records list 16 510(k) clearances for Boston Scientific Neuromodulation, from to . As of , FDA records show one recall naming K183579.

Clearance record

Decision date
Received
(98 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
Boston Scientific Neuromodulation 25155 Rye Canyon Loop, Valencia 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