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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 a medical device manufactured by Onward Medical, Inc.. It received FDA 510(k) clearance on 2025-11-14 under approval 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. It is manufactured by Onward Medical, Inc.. The 510(k) number is K251821.

When was ARC-EX System approved by the FDA?

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

What company makes ARC-EX System?

ARC-EX System is manufactured by Onward Medical, Inc..

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

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

Other Devices by Onward Medical, Inc.

DEN240014ARC-EX System

Related Devices (Code: SDO)

DEN240014ARC-EX SystemOnward Medical, Inc. 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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