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FDA 510(k)

Arthrex Spine Endoscope

K-Number: K243602 · 2025-05-16

ApplicantArthrex, Inc.
Decision Date2025-05-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Spine Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243602. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Spine Endoscope?

Arthrex Spine Endoscope is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Arthrex, Inc.. The 510(k) number is K243602.

When did Arthrex Spine Endoscope receive FDA 510(k) clearance?

Arthrex Spine Endoscope received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243602.

Who is the listed applicant for Arthrex Spine Endoscope?

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 Spine Endoscope?

The FDA product code for Arthrex Spine Endoscope is HRX.

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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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