X-Guide Surgical Navigation System— 510(k) K232148

Name: FDA 510(k) clearance K232148
Creator: U.S. Food and Drug Administration
Published: 2024-02-21

Substantially Equivalent

X-Nav Technologies, LLC

FDA 510(k) clearance K232148 for X-Guide Surgical Navigation System, Substantially Equivalent on 2024-02-21. Applicant: X-Nav Technologies, LLC. Device class: 2.

Clearance details

Applicant: X-Nav Technologies, LLC
Product code: Code QRY
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2023-07-19
Decision date: 2024-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRY

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K253954 — X-Guide Surgical Navigation System2026-08-28
K222750 — Yomi Robotic System2022-12-08
K222049 — Yomi Robotic System2022-11-04
K211701 — X-Guide® Surgical Navigation System2022-02-01

More clearances from X-Nav Technologies, LLC

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K200662 — X-Guide® Surgical Navigation System2020-05-21
K192579 — X-Guide Surgical Navigation System2020-02-03
K150222 — X-Guide Surgical Navigation System2015-10-08

Recalls naming K232148

K-number listed on FDA's recall record

Z-1392-2024 — X-Guide Handpiece Adaptor Sleeve 1, Model P010701Class II·Ongoing·X-NAV Technologies, LLC·20240304
Z-1393-2024 — X-Guide Handpiece Adaptor Sleeve 3, Model P010727Class II·Ongoing·X-NAV Technologies, LLC·20240304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232148.

Data sourced from openFDA. This site is unofficial and independent of the FDA.