K232865 is an FDA 510(k) clearance for the Magseed Pro Magnetic Marker System. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.
Submitted by Endomagnetics Ltd., (Cambridge, GB). The FDA issued a Cleared decision on June 28, 2024 after a review of 287 days - an extended review cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Endomagnetics Ltd., devices
NCT05142787
Recruiting
Interventional
Industry-sponsored
Magseed Pro(R)/ Sentimag(R) Gen3
A Prospective, Multi Center, International, Open Label Study of the Use of Magseed Pro(R) Markers and Sentimag(R) Gen3 to Localize Breast Lesions and Suspicious/biopsy-proven Positive Lymph Nodes in Breast Cancer Patients
| Condition studied |
Breast Cancer |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Stefan Paepke, Dr |
| Sponsor |
Endomagnetics Ltd.
(industry)
|
Started 2023-03-02
→
Primary completion 2025-12-31
→
Completed 2026-06-30
Primary outcome
The primary endpoints are the retrieval rates of the Magseed Pro® marker with the target lesion within the initial excised specimen for A.) axillary lymph nodes B.) breast lesions A.) axillary lymph nodes. B.) breast lesions
Secondary outcome
Tissue response (unexpected and expected)
View full study on ClinicalTrials.gov