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FDA 510(k)

Digital ClarusScope System and Digital NeuroPEN System

K-Number: K252790 · 2026-05-26

ApplicantClarus Medical, LLC
Decision Date2026-05-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Digital ClarusScope System and Digital NeuroPEN System is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K252790. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital ClarusScope System and Digital NeuroPEN System?

Digital ClarusScope System and Digital NeuroPEN System is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Clarus Medical, LLC. The 510(k) number is K252790.

When did Digital ClarusScope System and Digital NeuroPEN System receive FDA 510(k) clearance?

Digital ClarusScope System and Digital NeuroPEN System received FDA 510(k) clearance on 2026-05-26, under 510(k) number K252790.

Who is the listed applicant for Digital ClarusScope System and Digital NeuroPEN System?

The FDA 510(k) record lists Clarus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital ClarusScope System and Digital NeuroPEN System?

The FDA product code for Digital ClarusScope System and Digital NeuroPEN System is HRX.

Other records listing Clarus Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240535Digital ClarusScope System; Digital NeuroPEN SystemK223615Digital ClarusScope System, Digital NeuroPEN SystemK200925Clarus Peel-Away Introducer Sheath

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLCK252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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