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Probe

by Phx Technologies Corp.

510(k) K954476

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954476 Date23 Oct 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Probe is an orthopedic device with product code HRX. It is classified as a Class 2 device. The device is substantially equivalent to other devices on the market.

The Probe is supplied by Phx Technologies Corp. and has been cleared through the Traditional 510(k) pathway. It has FDA 510(k) clearance, with the clearance number K954476. The device is used in orthopedic applications.

Other devices from Phx Technologies Corp.

See all devices from Phx Technologies Corp. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Probe device used for?

    The Probe device is used in orthopedic applications, providing a solution for specific orthopedic needs.

  • How is the Probe device supplied?

    The Probe device is supplied by Phx Technologies Corp., the manufacturer of the device.

  • What is the regulatory status of the Probe device?

    The Probe device has FDA 510(k) clearance, with the clearance number K954476, indicating it has been cleared through the Traditional 510(k) pathway.