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FDA 510(k)

Magseed Magnetic Marker Systtem

K-Number: K173587 · 2018-02-16

ApplicantEndomagnetics Ltd.,
Decision Date2018-02-16
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Magseed Magnetic Marker Systtem is the device name listed in this FDA 510(k) record. The listed applicant is Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K173587. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magseed Magnetic Marker Systtem?

Magseed Magnetic Marker Systtem is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K173587.

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

Magseed Magnetic Marker Systtem received FDA 510(k) clearance on 2018-02-16, under 510(k) number K173587.

Who is the listed applicant for Magseed Magnetic Marker Systtem?

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 Systtem?

The FDA product code for Magseed Magnetic Marker Systtem is NEU.

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 SystemK163541Magseed Magnetic Marker SystemK153044Sentimag System, Sentimark Magnetic Marker Systerm

Related Devices (Code: NEU)

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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

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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