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FDA 510(k)

Tumark Vision

K-Number: K180443 · 2018-03-22

ApplicantSomatex Medical Technologies GmbH
Decision Date2018-03-22
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tumark Vision is the device name listed in this FDA 510(k) record. The listed applicant is Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K180443. 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 Tumark Vision?

Tumark Vision is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K180443.

When did Tumark Vision receive FDA 510(k) clearance?

Tumark Vision received FDA 510(k) clearance on 2018-03-22, under 510(k) number K180443.

Who is the listed applicant for Tumark Vision?

The FDA 510(k) record lists Somatex Medical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tumark Vision?

The FDA product code for Tumark Vision is NEU.

Other records listing Somatex Medical Technologies GmbH 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.

K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeK182082Tumark for Eviva, Tumark for Brevera

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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