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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 the device name listed in this FDA 510(k) record. The listed applicant is Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2017-01-13 under 510(k) 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. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K163541.

When did Magseed Magnetic Marker System receive FDA 510(k) clearance?

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

Who is the listed applicant for Magseed Magnetic Marker System?

The FDA 510(k) record lists Endomagnetics Ltd., as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Endomagnetics Ltd., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160053Lymph node location system during sentinel biopsy procedureK232865Magseed Pro Magnetic Marker SystemK222832Sentimag SystemK173587Magseed Magnetic Marker SysttemK153044Sentimag System, Sentimark Magnetic Marker Systerm

Related Devices (Code: PBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223682Sirius 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.K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.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.K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

Official Source

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

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