Digital ClarusScope System and Digital NeuroPEN System— 510(k) K252790

Name: FDA 510(k) clearance K252790
Creator: U.S. Food and Drug Administration
Published: 2026-05-26

Substantially Equivalent

Clarus Medical, LLC

FDA 510(k) clearance K252790 for Digital ClarusScope System and Digital NeuroPEN System, Substantially Equivalent on 2026-05-26. Applicant: Clarus Medical, LLC. Device class: 2.

Clearance details

Applicant: Clarus Medical, LLC
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2025-09-02
Decision date: 2026-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Clarus Medical, LLC

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K240535 — Digital ClarusScope System; Digital NeuroPEN System2024-04-25
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K200925 — Clarus Peel-Away Introducer Sheath2021-03-18
K082038 — CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V2009-04-28
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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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 →

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