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 a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-05-08 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K254215.
When was Arthrex Beaming System approved by the FDA?
Arthrex Beaming System received FDA 510(k) clearance on 2026-05-08, under approval number K254215.
What company makes Arthrex Beaming System?
Arthrex Beaming System is manufactured by Arthrex, Inc..
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.
Related Devices (Code: HWC)
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.