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Instrument Clamps Electromagnetic

by Stryker Corporation

510(k) K202609

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK202609 Date9 Oct 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
PGW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
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 Instrument Clamps Electromagnetic is a medical device classified as a Class II device under the FDA 510(k) program. It is designed for use in neurology procedures, specifically for stereotaxic applications. The device is part of a broader category of ear, nose, and throat stereotaxic instruments.

The device is supplied as a reusable instrument and is not sterile. It is intended for use in clinical settings under the supervision of trained healthcare professionals. The device is not MRI-safe and must be stored in a dry environment to maintain its integrity. The device is authorized for use in the United States under FDA 510(k) clearance.

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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 Stryker Instrument Clamps Electromagnetic used for?

    This device is designed for use in neurology procedures, specifically for stereotaxic applications, as part of a broader category of ear, nose, and throat stereotaxic instruments.

  • Is the device sterile and single-use?

    No, the Instrument Clamps Electromagnetic is supplied as a reusable instrument and is not sterile. It must be used in clinical settings under the supervision of trained healthcare professionals.

  • What are the storage requirements for this device?

    To maintain its integrity, the device must be stored in a dry environment. It is important to note that it is not MRI-safe.

  • How is the device regulated in the United States?

    The device is classified as a Class II device and is authorized for use in the United States under FDA 510(k) clearance.