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Vulcan Tac Probes, Model 911XXX

by Oratec Interventions, Inc.

510(k) K003198

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 NumberK003198 Date29 Aug 2001ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Vulcan Tac Probes, Model 911XXX are arthroscopic instruments intended to make visible the interior of a joint. These probes are designed for use during arthroscopic procedures to examine and treat joint conditions.

The device is supplied as a single-use or reusable instrument and is available in various sizes. It is classified under product code HRX and received FDA 510(k) clearance on August 29, 2001, with K number K003198. The device is intended for orthopedic procedures and is manufactured by Oratec Interventions, Inc.

Other devices from Oratec Interventions, Inc.

See all devices from Oratec Interventions, Inc. →

Questions

AI-generated answers, 26 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 are the Vulcan Tac Probes used for?

    The Vulcan Tac Probes, Model 911XXX are arthroscopic instruments designed to make the interior of a joint visible during arthroscopic procedures. They are used to examine and treat various joint conditions in orthopedic procedures.

  • Are the Vulcan Tac Probes single-use or reusable?

    The Vulcan Tac Probes are supplied as either single-use or reusable instruments, depending on the specific configuration selected for clinical use. This flexibility allows healthcare providers to choose the appropriate option for their practice needs.

  • What sizes and models are available for the Vulcan Tac Probes?

    The Vulcan Tac Probes are available in various sizes to accommodate different clinical requirements during arthroscopic procedures. The specific size options should be selected based on the particular joint being examined and the nature of the procedure being performed.

  • What is the regulatory status of the Vulcan Tac Probes?

    The Vulcan Tac Probes, Model 911XXX received FDA 510(k) clearance on August 29, 2001, with K number K003198. They are classified under product code HRX and are manufactured by Oratec Interventions, Inc.