Skip to content

Stimuplex Onvision System

by Philips Medical Systems Nederland B.V.

510(k) K192914

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192914↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK192914 Date27 May 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Stimuplex Onvision System is a conduction needle for anesthetic use, designed to facilitate peripheral nerve stimulation and block procedures in anesthesiology. It combines visual feedback with nerve stimulation to enhance precision during regional anesthesia applications, aiding clinicians in identifying optimal needle placement for effective nerve conduction.

This system is supplied as a reusable medical device and is intended for use in clinical settings where peripheral nerve blocks are performed. It adheres to FDA 510(k) clearance under regulation 21 CFR 868.5150, classified as a Class II device under the Product Code BSP. The device is regulated for use in anesthesiology and is intended for single-use needles, though the system itself may be reusable depending on manufacturer guidelines.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Questions

AI-generated answers, 18 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 primary purpose of the Stimuplex Onvision System in clinical practice?

    The Stimuplex Onvision System is designed to assist anesthesiologists during peripheral nerve block procedures by combining visual feedback with nerve stimulation. This integration helps clinicians achieve precise needle placement, improving the accuracy and effectiveness of regional anesthesia applications.

  • Is the Stimuplex Onvision System intended for single-use or reusable applications?

    The system itself is reusable, but it is paired with single-use conduction needles for anesthetic procedures. The reusable components adhere to manufacturer guidelines for reuse, while the needles are replaced after each use to ensure sterility and safety.

  • How is the Stimuplex Onvision System regulated, and what does that mean for its use?

    The Stimuplex Onvision System holds both FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and effectiveness. It is classified as a Class II device under Product Code BSP, indicating it is intended for use in anesthesiology and adheres to specific regulatory pathways for peripheral nerve stimulation and block procedures.

  • Are there different sizes or models available for the Stimuplex Onvision System, and if so, how are they specified?

    The system includes multiple single-use conduction needles, each with distinct registration numbers (e.g., 3030626857, 1018233, etc.), which likely correspond to varying sizes or gauges. These needles are part of the system’s design to accommodate different clinical needs for peripheral nerve block procedures, though exact specifications like gauge or length are not detailed in the provided data.