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Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees)

by Stryker Corporate

510(k) K141551

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141551 Date8 Sep 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2071-2017 FDA Class II initiated 10 Mar 2017

    Product shipped proximate to or past the expiration date listed on the product label.

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  • Withdrawn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
PGW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is an Ear, Nose, And Throat Stereotaxic Instrument as defined in the nomenclature authority. It is an intraoperative image-guided surgery (IGS) navigation system for intranasal and sinus procedures.

The system utilizes a computer workstation (Stryker ADAPT, Nav3, or Nav3i) running navigation software. It is supplied as a software component with associated curved suction instruments at 70 and 90 degrees. The device received FDA 510(k) clearance under K141551, is classified as Class II, and falls under regulation number 882.4560 with neurology as the medical specialty.

Other devices from Stryker Corporate

Questions

AI-generated answers, 25 Sep 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 PROFESS system used for?

    The PROFESS system is an intraoperative image-guided surgery (IGS) navigation system designed for intranasal and sinus procedures, enabling surgeons to navigate with real-time imaging during ENT operations.

  • How is the PROFESS system supplied and what components does it include?

    The PROFESS system is supplied as a software component that runs on Stryker ADAPT, Nav3, or Nav3i computer workstations, and includes associated curved suction instruments at 70 and 90 degrees for use during surgery.

  • Is the PROFESS system reusable or single-use?

    The PROFESS system includes a reusable software component and reusable curved suction instruments; however, specific reuse protocols depend on the instrument design and manufacturer instructions, which are not detailed in the provided data.

  • What regulatory pathway was used for the PROFESS system?

    The PROFESS system received FDA 510(k) clearance under submission K141551, indicating it was found substantially equivalent to a legally marketed predicate device.

  • What is the device classification and medical specialty for the PROFESS system?

    The PROFESS system is classified as a Class II device under regulation number 882.4560, with neurology listed as the medical specialty in its FDA documentation.