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FDA 510(k)

Arthrex Synergy Vision Imaging System

K-Number: K251994 · 2025-10-16

ApplicantArthrex, Inc.
Decision Date2025-10-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arthrex Synergy Vision Imaging 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 2025-10-16 under 510(k) number K251994. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Synergy Vision Imaging System?

Arthrex Synergy Vision Imaging System is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Arthrex, Inc.. The 510(k) number is K251994.

When did Arthrex Synergy Vision Imaging System receive FDA 510(k) clearance?

Arthrex Synergy Vision Imaging System received FDA 510(k) clearance on 2025-10-16, under 510(k) number K251994.

Who is the listed applicant for Arthrex Synergy Vision Imaging 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 Synergy Vision Imaging System?

The FDA product code for Arthrex Synergy Vision Imaging System is GCJ.

Other records listing Arthrex, Inc. 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.

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Related Devices (Code: GCJ)

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.

Official Source

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