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FDA 510(k)

TISSUE MARKER

K-Number: K113202 · 2012-02-28

ApplicantFocal Therapeutics
Decision Date2012-02-28
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2012-02-28 under 510(k) number K113202. 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 TISSUE MARKER?

TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2012-02-28. The listed applicant is Focal Therapeutics. The 510(k) number is K113202.

When did TISSUE MARKER receive FDA 510(k) clearance?

TISSUE MARKER received FDA 510(k) clearance on 2012-02-28, under 510(k) number K113202.

Who is the listed applicant for TISSUE MARKER?

The FDA 510(k) record lists Focal Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TISSUE MARKER?

The FDA product code for TISSUE MARKER is NEU.

Related Clinical Trials

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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Other records listing Focal Therapeutics 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.

K192371BioZorb SP MarkerK171467BioZorb Marker GOLD / LP Marker GOLD

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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