DeviceClearance

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— 510(k) K183579

Substantially Equivalent

Boston Scientific Neuromodulation

FDA 510(k) clearance K183579 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, Substantially Equivalent on 2019-03-29. Applicant: Boston Scientific Neuromodulation. Device class: 2.

Clearance details

Applicant
Boston Scientific Neuromodulation
Product code
Code GZF
Device class
Class 2
Regulation
21 CFR 882.5870
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valencia, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GZF

view all

More clearances from Boston Scientific Neuromodulation

view all

Adverse events under product code GZF

product code GZF
Death
10
Injury
2,410
Other
1
Total
2,421

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

Recalls naming K183579

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183579.

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