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X-Guide P011803

by X-Nav Technologies, LLC

X-Guide P011803 is a surgical planning/navigation-enhancement system (FDA Class II) made by X-Nav Technologies, LLC, cleared under FDA 510(k) K232148 on 21 Feb 2024 (2 earlier submissions) and listed in FDA GUDID since 8 Oct 2024 (UDI-DI 00817421022791), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817421022791 UDI-DI Date8 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232148 Date21 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232148 decided 21 Feb 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00817421022791 listed 8 Oct 2024 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1393-2024 FDA Class II initiated 4 Mar 2024
    • Ongoing Z-1392-2024 FDA Class II initiated 4 Mar 2024

    The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

    • Terminated Z-1391-2016 FDA Class II initiated 23 Feb 2016

    The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3

Timeline

7 dated events

  1. Cleared FDA 510(k) K150222
  2. Recall initiated FDA recalls Z-1391-2016
  3. Cleared FDA 510(k) K200662
  4. Cleared FDA 510(k) K232148
  5. Recall initiated FDA recalls Z-1393-2024
  6. Recall initiated FDA recalls Z-1392-2024
  7. Listed FDA GUDID 00817421022791

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-Guide
Generic name
Surgical planning/navigation-enhancement system
Model / reference
P011803
Primary DI / UDI-DI
00817421022791
510(k) Number
FDA product code
PLV, QRY
GMDN term
Surgical planning/navigation-enhancement system
Device class
Class II
Regulation number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical planning/navigation-enhancement system

Cleared under the same submission (K150222)

and 8 more cleared under K150222

Cleared under the same submission (K200662)

and 8 more cleared under K200662

Similar devices in this category

Other devices filed under Surgical planning/navigation-enhancement system.

Other devices from X-Nav Technologies, LLC

  • X-Guide P011265

    Class II

  • X-Guide P011266

    Class II

  • X-Guide P011268

    Class II

  • X-Guide P011271

    Class II

See all devices from X-Nav Technologies, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)