DeviceClearance

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM— 510(k) K091457

Substantially Equivalent

Nexstim OY

FDA 510(k) clearance K091457 for NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM, Substantially Equivalent on 2009-12-08. Applicant: Nexstim OY. Device class: 2.

Clearance details

Applicant
Nexstim OY
Product code
Code GWF
Device class
Class 2
Regulation
21 CFR 882.1870
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
North Attleboro, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Nexstim OY

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Adverse events under product code GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

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 K091457

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 K091457.

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