Magseed Pro Magnetic Marker System

FDA 510(k) K232865 · Endomagnetics Ltd.,

Substantially Equivalent

510(k) numberK232865

Submission

Device name
Magseed Pro Magnetic Marker System
Applicant
Endomagnetics Ltd.,
Cambridge, GB
Received
September 15, 2023
Decision date
June 28, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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More from Molli Surgical, Inc.

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K222832Sentimag SystemNEU · Traditional 01/21/2023SE
K173587Magseed Magnetic Marker SysttemNEU · Traditional 02/16/2018SE
K163541Magseed Magnetic Marker SystemPBY · Special 01/13/2017SE
K153044Sentimag System, Sentimark Magnetic Marker SystermPBY · Traditional 03/02/2016SE

Questions and answers

When was Magseed Pro Magnetic Marker System cleared by the FDA?

Magseed Pro Magnetic Marker System (K232865) received a 510(k) decision of Substantially Equivalent on June 28, 2024, 287 days after the submission was received.

What is the product code of K232865?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.