Magseed Pro Magnetic Marker System— 510(k) K232865
Substantially EquivalentEndomagnetics Ltd.,
FDA 510(k) clearance K232865 for Magseed Pro Magnetic Marker System, Substantially Equivalent on 2024-06-28. Applicant: Endomagnetics Ltd.,. Device class: 2.
Clearance details
- Applicant
- Endomagnetics Ltd.,
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, GB
Recent devices under product code NEU
view allMore clearances from Endomagnetics Ltd.,
view allAdverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K232865
K-number listed on FDA's recall record- Z-0316-2026 — Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic 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.
- Z-0317-2026 — Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232865.
Data sourced from openFDA. This site is unofficial and independent of the FDA.