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FDA 510(k)

ARC-EX System

K-Number: K251821 · 2025-11-14

ApplicantOnward Medical, Inc.
Decision Date2025-11-14
Product CodeSDO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ARC-EX System is the device name listed in this FDA 510(k) record. The listed applicant is Onward Medical, Inc.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K251821. The device is classified under product code SDO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARC-EX System?

ARC-EX System is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Onward Medical, Inc.. The 510(k) number is K251821.

When did ARC-EX System receive FDA 510(k) clearance?

ARC-EX System received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251821.

Who is the listed applicant for ARC-EX System?

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

What is the FDA product code for ARC-EX System?

The FDA product code for ARC-EX System is SDO.

Related Clinical Trials

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.

NCT07147296ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord InjuryRECRUITING

Related Devices (Code: SDO)

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.

K253638xStep (xStep)Spinex, Inc.K252893ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)Aneuvo

Official Source

View on FDA Database →

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

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