# X-Guide P008802

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/x-guide-p008802>
- Manufacturer: [X-Nav Technologies, LLC](https://devicerts.com/manufacturers/x-nav-technologies-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: PLV
- GMDN: Surgical planning/navigation-enhancement system (61496)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00817421020216 · listed 2016-09-30 · status: Listed (GUDID: not in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K150222 · decision 2015-10-08 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1391-2016 · Class II · terminated · initiated 2016-02-23: 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

## Identity

- Trade name: X-Guide [FDA GUDID (AccessGUDID)]
- Generic name: Surgical planning/navigation-enhancement system [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: P008802 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00817421020216 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K150222 [FDA GUDID (AccessGUDID)]
- FDA product code: PLV [FDA GUDID (AccessGUDID)]
- GMDN term: Surgical planning/navigation-enhancement system (61496) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 872.4120 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: X-Guide P008802, X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/x-guide-p008802 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/x-guide-p008802.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/x-guide-p008802
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.