Who else makes this device?

Name: Sentimag Footswitch Assembly
Brand: Sentimag Footswitch Assembly

General & Plastic Surgery › SurgicalMarker, Radiographic, Implantable

Sentimag Footswitch Assembly

Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel…

Registry build 21.09.26

Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.

1manufacturer

1catalogue number

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code NEU
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Sentimag Footswitch Assembly
Listed by	Endomagnetics Ltd, United Kingdom
FDA product code	NEU
Device type	Marker, Radiographic, Implantable
Device class	Class 2
Regulation	21 CFR 878.4300
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2023-06-20
Record revised	2026-01-27 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Sentimag Footswitch Assembly
Catalogue number	Size	Status
SMA		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HydroMARK	Devicor Medical Products, Inc.	75
Scout®	Merit Medical Systems, Inc.	68
Scout MD™	Merit Medical Systems, Inc.	46
SmartClip	Elucent Medical Inc.	37
BiomarC®	Carbon Medical Technologies, Inc.	25
HydroMARK Breast Biopsy Site Marker	Devicor Medical Products, Inc.	21
SecurMark	Hologic, Inc.	15
Gold Marker	Riverpoint Medical LLC	15
MammoStar™	Carbon Medical Technologies, Inc.	15
SecurMark for Atec	Hologic, Inc.	15
SenoMark® Ultra Breast Tissue Marker	Bard Peripheral Vascular, Inc.	14
TriMark	Hologic, Inc.	14

Showing 12 of 96. All products under Marker, Radiographic, Implantable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232865	2024-06-28
K222832	2023-01-21
K173587	2018-02-16

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-10-01	Class II	Process control	Potential for contamination with cotton fibers.	540 units
2025-10-01	Class II	Process control	Potential for contamination with cotton fibers.	1,760 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.