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FDA 510(k)

Magseed Magnetic Marker System

K-Number: K163541 · 2017-01-13

ApplicantEndomagnetics Ltd.,
Decision Date2017-01-13
Product CodePBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Magseed Magnetic Marker System is a medical device manufactured by Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2017-01-13 under approval number K163541. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magseed Magnetic Marker System?

Magseed Magnetic Marker System is a medical device that received FDA 510(k) clearance on 2017-01-13. It is manufactured by Endomagnetics Ltd.,. The 510(k) number is K163541.

When was Magseed Magnetic Marker System approved by the FDA?

Magseed Magnetic Marker System received FDA 510(k) clearance on 2017-01-13, under approval number K163541.

What company makes Magseed Magnetic Marker System?

Magseed Magnetic Marker System is manufactured by Endomagnetics Ltd.,.

What is the FDA product code for Magseed Magnetic Marker System?

The FDA product code for Magseed Magnetic Marker System is PBY.

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Other Devices by Endomagnetics Ltd.,

K153044Sentimag System, Sentimark Magnetic Marker Systerm K173587Magseed Magnetic Marker Systtem K222832Sentimag System K232865Magseed Pro Magnetic Marker System PMA P160053Lymph node location system during sentinel biopsy procedure

Related Devices (Code: PBY)

K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)Health Beacons, Inc. K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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