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Probe Refill Kit

by Interspec, Inc.

510(k) K911073

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 NumberK911073 Date6 Jun 1991ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Probe Refill Kit is a Class II ultrasound system used in radiology. It is substantially equivalent to other devices and has a product code of ITX. The device is manufactured by Interspec, Inc.

The Probe Refill Kit is supplied with an FDA 510K clearance, specifically under K-number K911073, which was cleared in 1991 through the Traditional 510(k) pathway. The device has a single clearance and is classified as a Radiology device.

Other devices from Interspec, Inc.

See all devices from Interspec, Inc. →

Questions

AI-generated answers, 27 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 Probe Refill Kit used for?

    The Probe Refill Kit is used in radiology as part of an ultrasound system.

  • Is the Probe Refill Kit supplied sterile?

    The device data does not specify if the Probe Refill Kit is supplied sterile, contact the manufacturer for more information.

  • What is the regulatory clearance for the Probe Refill Kit?

    The Probe Refill Kit has an FDA 510K clearance under K-number K911073, cleared through the Traditional 510(k) pathway in 1991.