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FDA 510(k)

Arthrex Beaming System

K-Number: K254215 · 2026-05-08

ApplicantArthrex, Inc.
Decision Date2026-05-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Beaming System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K254215. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Beaming System?

Arthrex Beaming System is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Arthrex, Inc.. The 510(k) number is K254215.

When did Arthrex Beaming System receive FDA 510(k) clearance?

Arthrex Beaming System received FDA 510(k) clearance on 2026-05-08, under 510(k) number K254215.

Who is the listed applicant for Arthrex Beaming System?

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

What is the FDA product code for Arthrex Beaming System?

The FDA product code for Arthrex Beaming System is HWC. This falls under the Cardiovascular category.

Other records listing Arthrex, Inc. as applicant

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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.

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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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