Sentimag System— 510(k) K222832

Name: FDA 510(k) clearance K222832
Creator: U.S. Food and Drug Administration
Published: 2023-01-21

Substantially Equivalent

Endomagnetics Ltd.,

FDA 510(k) clearance K222832 for Sentimag System, Substantially Equivalent on 2023-01-21. 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: 2022-09-20
Decision date: 2023-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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K173587 — Magseed Magnetic Marker Systtem2018-02-16
K163541 — Magseed Magnetic Marker System2017-01-13
K153044 — Sentimag System, Sentimark Magnetic Marker Systerm2016-03-02

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.