NerveGuard NRFit, NerveGuard LUER— 510(k) K170435

Clearance details

Applicant

PAJUNK GmbH Medizintechnologie

Product code

Code BSP

Device class

Class 2

Regulation

21 CFR 868.5150

Advisory panel

Anesthesiology

Date received

2017-02-13

Decision date

2017-07-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Geisingen, DE

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Death

2

Total

2

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 →