Chrysalis Intelligence · Sponsors · Endomagnetics Ltd.,

Endomagnetics Ltd.,

Cambridge, GB · 2 510(k) clearances · 8 PMAs

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Total clearances
2
2023-01-21 → 2024-06-28
Last 12 months
0
Product codes
1
Most recent
2024-06-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NEU Marker, Radiographic, Implantable Class II General, Plastic Surgery 2 2024-06-28
Class III

PMA approvals (8)

Total PMA records
8
Originals + supplements
Distinct product codes
1
First decision
2021-09-20
Most recent
2026-05-18
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-18 P160053-S012 MagtraceTM and Sentimag(R) Magnetic Locatization System 30-Day Notice PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2024-07-03 P160053-S011 Magtrace® and Sentimag® Magnetic Locatization System (PUV) Normal 180 Day Track No User Fee PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2024-06-07 P160053-S010 Magtrace and Sentimag Magnetic Locatization System (PUV) Normal 180 Day Track No User Fee PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2024-04-15 P160053-S009 Magtrace and Sentimag Magnetic Localization System Normal 180 Day Track PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2023-06-29 P160053-S007 Magtrace® and Sentimag® Magnetic Locatization System (PUV) Normal 180 Day Track No User Fee PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2022-12-06 P160053-S002 MagtraceTM and Sentimag(R) Magnetic Locatization System Panel Track PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2022-09-13 P160053-S005 MagtraceTM and Sentimag(R) Magnetic Locatization System Normal 180 Day Track PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
2021-09-20 P160053-S004 Magtrace/and Sentimag Magnetic Localization System Normal 180 Day Track No User Fee PUV Lymph Node Location System During Sentinel Biopsy Procedure Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2024-06-28 K232865 Magseed Pro Magnetic Marker System NEU Class II General, Plastic Surgery
2023-01-21 K222832 Sentimag System NEU Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence