Sentimag System, Sentimark Magnetic Marker System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153044 FDA 510(k)
- FDA Product Code
- PBY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sentimag System, Sentimark Magnetic Marker System is a temporary tissue marker used for marking tissue sites in the breast. It is intended to be placed percutaneously in the breast to mark a lumpectomy site for surgical removal within 30 days.
The system is used with imaging guidance such as ultrasound or radiography, or with nonimaging guidance from the Sentimag system, to locate and surgically remove the magnetic marker along with the target tissue. It is supplied as a sterile, single-use device and is authorized under FDA 510(k) clearance K153044 for general and plastic surgery applications.
Frequently asked questions
What is the Sentimag System with Sentimark Magnetic Marker used for?
It is used to mark tissue sites in the breast percutaneously, specifically to identify a lumpectomy site for surgical removal within 30 days, using imaging or nonimaging guidance from the Sentimag system to locate and remove the marker with target tissue.
How is the Sentimag System supplied and is it reusable?
The device is supplied as a sterile, single-use system and is not intended for reuse; each unit is designed for one patient procedure only to maintain sterility and prevent cross-contamination.
What guidance methods can be used with the Sentimag System for marker placement and removal?
The system can be used with imaging guidance such as ultrasound or radiography, or with nonimaging guidance provided by the Sentimag system itself, to accurately locate and surgically remove the magnetic marker along with the target tissue.
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: Endomag® Magseed & Sentimag | Magnetic Localization | Hologic, Sentimag System, Sentimark Magnetic Marker Systerm (K153044) — FDA 510 ..., Sentimag System, Sentimark Magnetic Marker Systerm, Sentimag System (K222832) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153044 | Class II | Active |
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Manufacturer
- Manufacturer
- Endomagnetics Ltd
- FDA Applicant
- Endomagnetics Ltd.,
Sources (1)
- FDA 510(k) K153044 24 fields · synced Sep 27, 2026