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DryTouch Suction Stimulator Probe

by Neurovision Medical Products, Inc.

510(k) K110712

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 NumberK110712 Date28 Jun 2011ClearedStatusActive

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  • Withdrawn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
ETN
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 DryTouch Suction Stimulator Probe is a dedicated manual surgical instrument that integrates precision suction with triggered monopolar stimulation for continuous nerve monitoring with tEMG. It allows surgeons to clear secretions and test surgical tissue with nerve stimulation simultaneously using the same instrument. This device is designed to maintain a clear surgical field while enhancing nerve preservation during procedures.

The DryTouch Suction Stimulator Probe is intended for use only by a licensed physician in conjunction with the Neurovision Nerve Locator Monitor System. It is supplied as a single-use device and requires appropriate storage conditions. The device has received FDA 510(k) clearance with product code ETN and is classified under regulation number 874.1820 for ear, nose, and throat procedures.

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Questions

AI-generated answers, 23 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 DryTouch Suction Stimulator Probe used for?

    The DryTouch Suction Stimulator Probe is a dedicated manual surgical instrument designed to integrate precision suction with triggered monopolar stimulation for continuous nerve monitoring with tEMG. It allows surgeons to clear secretions and test surgical tissue with nerve stimulation simultaneously using the same instrument, maintaining a clear surgical field while enhancing nerve preservation during procedures.

  • Is the DryTouch Suction Stimulator Probe a single-use device?

    Yes, the DryTouch Suction Stimulator Probe is supplied as a single-use device. It requires appropriate storage conditions and is intended for use only by a licensed physician in conjunction with the Neurovision Nerve Locator Monitor System.

  • What regulatory approvals does the DryTouch Suction Stimulator Probe have?

    The DryTouch Suction Stimulator Probe has received FDA 510(k) clearance with product code ETN and is classified under regulation number 874.1820 for ear, nose, and throat procedures. It was determined to be substantially equivalent to predicate devices.

  • What procedures is the DryTouch Suction Stimulator Probe indicated for?

    The DryTouch Suction Stimulator Probe is specifically designed for ear, nose, and throat procedures. It is intended to be used by licensed physicians in conjunction with the Neurovision Nerve Locator Monitor System to enhance nerve preservation during surgical procedures.