MagtraceTM and Sentimag(R) Magnetic Locatization System

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P160053510(k) K222832

by Endomagnetics Ltd

Identity

Trade Name: MagtraceTM and Sentimag(R) Magnetic Locatization System FDA PMA
Generic Name: Lymph node location system during sentinel biopsy procedure FDA PMA

Identifiers

PMA Number: P160053 FDA PMA
510(k) Number: K222832 FDA PMA
FDA Product Code: PUV FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: General, Plastic Surgery FDA PMA
FDA Decision: APPR Approved FDA PMA

The Magtrace and Sentimag Magnetic Localization System is a lymph node location system designed to assist in identifying lymph nodes that drain a tumor site. It is specifically indicated for use as part of a sentinel lymph node biopsy procedure in patients with breast cancer who are undergoing a mastectomy.

This system is comprised of the Magtrace agent and the Sentimag system, which are calibrated to function exclusively with one another. The device has received FDA 510K and PMA authorizations for its clinical application. It is intended for professional use in a surgical setting to support precise localization during oncology procedures.

Frequently asked questions

What is the primary purpose of the Magtrace and Sentimag system?

The system is used to assist surgeons in localizing lymph nodes that drain a tumor site, specifically during sentinel lymph node biopsy procedures for patients with breast cancer.

Can Magtrace be used with other magnetic localization devices?

No, Magtrace is specifically intended and calibrated for use only with the Sentimag system to ensure proper function and localization accuracy.

Is this system authorized for use in breast cancer surgery?

Yes, the system has received FDA 510K and PMA authorizations and is indicated for use in sentinel lymph node biopsy procedures for patients undergoing a mastectomy.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Premarket Approval (PMA) - FDA, HaRi · MagtraceTM and Sentimag(R) Magnetic Locatization System, ENDOMAGNETICS LTD FDA Filings - FDA.report, Magseed Pro(R)/ Sentimag(R) Gen3 | Clinical Trial, MagtraceTM and Sentimag(R) Magnetic Locatization System ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K222832	Class III	Active
FDA PMA	United States	FDA_PMA	P160053	Class III	Active

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Manufacturer

Manufacturer: Endomagnetics Ltd
FDA Applicant: Endomagnetics Ltd.,

Sources (2)

FDA PMA P160053 37 fields · synced Sep 18, 2026
FDA 510(k) K222832 1 fields · synced May 18, 2026