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The Tracker / August 2026 / K253954

510(k) cleared

X-Guide Surgical Navigation System

X-Nav Technologies, LLC · Aug 28, 2026 · K253954

FDA cleared the X-Guide Surgical Navigation System from X-Nav Technologies, LLC on Aug 28, 2026 under K253954, a traditional 510(k). The device falls under product code QRY, Dental Navigation System, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 10, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for X-Nav Technologies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253954?

K253954 is the FDA 510(k) for X-Guide Surgical Navigation System, submitted by X-Nav Technologies, LLC. FDA's decision date was Aug 28, 2026, under product code QRY (Dental Navigation System).

Who makes the X-Guide Surgical Navigation System?

X-Nav Technologies, LLC, based in Lansdale, PA, is the applicant of record for K253954.

How long did the K253954 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Aug 28, 2026, 261 days later.

← All decisions in August 2026