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Pari-Path Surgical Navigation System

by Paritic, Inc.

510(k) K133901

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 NumberK133901 Date27 Jun 2014ClearedStatusActive

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
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 Pari-Path Surgical Navigation System is a stereotactic accessory designed to assist in intra-operative navigation for Computed Tomography (CT) and Ultrasound imaging systems. It integrates with these modalities to provide precise spatial guidance during surgical procedures, enhancing accuracy and reducing procedural risks. This system is classified under the Radiology device category and is intended for use in interventional settings where real-time imaging and navigation are critical. Its functionality aligns with stereotactic techniques, enabling surgeons to correlate pre-operative planning with live imaging data during operations.

The system is supplied as a standalone accessory compatible with existing CT and Ultrasound platforms, requiring no additional regulatory approval beyond its FDA 510(k) clearance under product code JAK. It is intended for reusable use in clinical environments, with sterility maintained through standard medical device reprocessing protocols. The device is not MRI-safe, and its use is restricted to settings where CT or Ultrasound imaging is available. Storage and handling follow standard medical device guidelines to ensure functionality and safety for repeated surgical applications.

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 Pari-Path Surgical Navigation System used for?

    The Pari-Path Surgical Navigation System is designed to assist surgeons during intra-operative procedures by providing precise spatial guidance when integrated with Computed Tomography (CT) or Ultrasound imaging systems. It helps correlate pre-operative planning with real-time imaging data, enhancing accuracy and reducing risks in stereotactic surgeries where spatial precision is critical.

  • How is the Pari-Path Surgical Navigation System supplied and intended for use?

    The system is supplied as a standalone accessory compatible with existing CT and Ultrasound platforms. It is intended for reusable clinical use, with sterility maintained through standard medical device reprocessing protocols. No additional regulatory approval is required beyond its existing FDA 510(k) clearance.

  • Is the Pari-Path Surgical Navigation System single-use or reusable?

    The Pari-Path Surgical Navigation System is designed for reusable use in clinical settings. Sterility is maintained through adherence to standard medical device reprocessing protocols, ensuring safe and repeated applications in surgical environments.

  • What safety considerations should be noted when using the Pari-Path Surgical Navigation System?

    The system is not MRI-safe and should only be used in settings where CT or Ultrasound imaging is available. Storage and handling follow standard medical device guidelines to preserve functionality and safety for repeated use. Always ensure proper reprocessing and maintenance to comply with clinical protocols.

  • What regulatory approval does the Pari-Path Surgical Navigation System hold?

    The Pari-Path Surgical Navigation System holds FDA 510(k) clearance under product code JAK, classified as substantially equivalent under the Radiology device category. This clearance allows its use as a reusable accessory for CT and Ultrasound systems without requiring additional regulatory approvals.