Magseed Magnetic Marker System
ENDOMAGNETICS LTD
ENDOMAGNETICS LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012644426 | 3012644426 | ENDOMAGNETICS LTD | 1 | N | 2026-01-01 | 330 Cambridge Science Park Milton Road Cambridge Cambridgeshire GB CB4 0WN |
| 3012644426 | 3012644426 | ENDOMAGNETICS LTD | 1 | N | 2020-04-25 | Endomag, The Jeffreys Building, St Johns innovation Park, Cowley Road Cambridge Cambridgeshire GB CB4 0WS |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 345543 | 1087706653 | P160053 | MagtraceTM and Sentimag(R) Magnetic Locatization System | PUV | 2018-07-24 |
| 192535 | 1781482184 | P160053 | MagtraceTM and Sentimag(R) Magnetic Locatization System | PUV | 2018-07-24 |
| 345543 | 1871797829 | K232865 | Magseed Pro Magnetic Marker System | NEU | 2024-06-28 |
| 345543 | 1830109306 | K222832 | Sentimag System | NEU | 2023-01-21 |
| 345543 | 1916766950 | K173587 | Magseed Magnetic Marker Systtem | NEU | 2018-02-16 |
| 192535 | 1971910537 | K173587 | Magseed Magnetic Marker Systtem | NEU | 2018-02-16 |
| 345543 | 1243372140 | K163541 | Magseed Magnetic Marker System | PBY | 2017-01-13 |
| 192535 | 1944728634 | K163541 | Magseed Magnetic Marker System | PBY | 2017-01-13 |
| 345543 | 1410986230 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | PBY | 2016-03-02 |
| 192535 | 1934675809 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | PBY | 2016-03-02 |
| 345543 | 1051975303 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
2024-08-15
Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
2024-08-15
Magseed - Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.
2023-06-20
Magseed - Magseed Magnetic Tissue Marker Length 7cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.
2023-06-20
Sentimag Cart - The Sentimag Cart is indicated for use as a mobile support and storage accessory for the Sentimag Gen2 and Gen3 Systems. It is used to position, transport and store the Sentimag Systems during procedures for which they are indicated
2026-07-07
Magtrace - MTVC10-US
2026-05-15
Magtrace - Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.
2023-06-20
Sentimag - Standard Probe for Sentimag Gen 3
2024-02-09
Sentimag - Footswitch for Sentimag Gen 3
2024-02-09
Sentimag - Probe checker for Sentimag Gen 3 Probe
2024-02-09
Sentimag - Sentimag Gen 3 Base Unit
2024-02-09
Sentimag - Thin Probe for Sentimag Gen 3
2024-02-09
Sentimag Base Unit - The Sentimag system 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.
2023-06-20
Sentimag SMP02 Probe Assembly - Device Description: The Sentimag 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.
2023-06-20
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 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.
2023-06-20
Sentimag SMC02 Probe Test Phantom - 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.
2023-06-20
Sentimag SMH02 Probe Holder - 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.
2023-06-20
Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
2024-08-15
Magseed Pro - The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
2024-08-15