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FDA 510(k)

Sentimag System, Sentimark Magnetic Marker Systerm

K-Number: K153044 · 2016-03-02

ApplicantEndomagnetics Ltd.,
Decision Date2016-03-02
Product CodePBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sentimag System, Sentimark Magnetic Marker Systerm is the device name listed in this FDA 510(k) record. The listed applicant is Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K153044. 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 Sentimag System, Sentimark Magnetic Marker Systerm?

Sentimag System, Sentimark Magnetic Marker Systerm is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K153044.

When did Sentimag System, Sentimark Magnetic Marker Systerm receive FDA 510(k) clearance?

Sentimag System, Sentimark Magnetic Marker Systerm received FDA 510(k) clearance on 2016-03-02, under 510(k) number K153044.

Who is the listed applicant for Sentimag System, Sentimark Magnetic Marker Systerm?

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 Sentimag System, Sentimark Magnetic Marker Systerm?

The FDA product code for Sentimag System, Sentimark Magnetic Marker Systerm 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 SysttemK163541Magseed Magnetic Marker System

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.K163541Magseed Magnetic Marker SystemEndomagnetics 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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