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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 a medical device manufactured by Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2016-03-02 under approval 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. It is manufactured by Endomagnetics Ltd.,. The 510(k) number is K153044.

When was Sentimag System, Sentimark Magnetic Marker Systerm approved by the FDA?

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

What company makes Sentimag System, Sentimark Magnetic Marker Systerm?

Sentimag System, Sentimark Magnetic Marker Systerm is manufactured by Endomagnetics Ltd.,.

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Other Devices by Endomagnetics Ltd.,

K163541Magseed Magnetic Marker System K173587Magseed Magnetic Marker Systtem K222832Sentimag System K232865Magseed Pro Magnetic Marker System PMA P160053Lymph node location system during sentinel biopsy procedure

Related Devices (Code: PBY)

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., 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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