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FDA 510(k)

Sentimag System

K-Number: K222832 · 2023-01-21

ApplicantEndomagnetics Ltd.,
Decision Date2023-01-21
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sentimag 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 2023-01-21 under 510(k) number K222832. 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 Sentimag System?

Sentimag System is a medical device that received FDA 510(k) clearance on 2023-01-21. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K222832.

When did Sentimag System receive FDA 510(k) clearance?

Sentimag System received FDA 510(k) clearance on 2023-01-21, under 510(k) number K222832.

Who is the listed applicant for Sentimag 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 Sentimag System?

The FDA product code for Sentimag System 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.

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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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