Cleared Special

K163541 - Magseed Magnetic Marker System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163541 · Endomagnetics Ltd., · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
28d
Days
Class 2
Risk

K163541 is an FDA 510(k) clearance for the Magseed Magnetic Marker System. Classified as Temporary Tissue Marker (product code PBY), Class II - Special Controls.

Submitted by Endomagnetics Ltd., (Cambridge, GB). The FDA issued a Cleared decision on January 13, 2017 after a review of 28 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endomagnetics Ltd., devices

Submission Details

510(k) Number K163541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date January 13, 2017
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PBY Temporary Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBY Temporary Tissue Marker

Devices cleared under the same product code (PBY) and FDA review panel - the closest regulatory comparables to K163541.
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