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Tissue Marker

by Focal Therapeutics 510(k)

Active United States

510(k) K113202

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113202 Date28 Feb 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NEU
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tissue Marker is a radiographic, implantable device designed for marking soft tissue sites. It is classified as a Class II medical device and serves as a visible reference for future medical procedures, including surgical interventions, through radiographic imaging.

This device is supplied as a single-use, sterile implant intended for subcutaneous or soft tissue placement. It is non-magnetic and MRI-safe, with no reported restrictions on imaging modalities. The Tissue Marker is authorized under FDA 510(k) clearance (K113202) and falls under regulation number 878.4300, categorized under product code NEU. Storage and handling follow standard sterile implant protocols.

Other devices from Focal Therapeutics

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tissue Marker primarily used for in clinical settings?

    The Tissue Marker is designed as a radiographic, implantable device for marking soft tissue sites. Its purpose is to serve as a visible reference during future medical procedures, such as surgeries, by appearing clearly on radiographic imaging. This helps clinicians locate specific anatomical landmarks with precision.

  • Is the Tissue Marker safe to use with MRI machines, and are there any imaging restrictions?

    Yes, the Tissue Marker is explicitly labeled as MRI-safe and non-magnetic, meaning it can be used without restrictions in MRI environments. There are no reported limitations on imaging modalities, making it versatile for various diagnostic and procedural settings.

  • How should the Tissue Marker be stored and handled to maintain sterility?

    The Tissue Marker is supplied as a single-use, sterile implant, so it must be stored and handled according to standard sterile implant protocols. This ensures its integrity and safety for direct subcutaneous or soft tissue placement during procedures.

  • What regulatory pathway was followed for FDA clearance of the Tissue Marker?

    The Tissue Marker received FDA clearance through a 510(k) submission (K113202) under the Traditional review pathway, determined to be Substantially Equivalent to a predicate device. It falls under product code NEU (Neurosurgery) and regulation number 878.4300, with advisory input from the General, Plastic Surgery committee.

  • Can the Tissue Marker be reused, or is it intended for single-use only?

    The Tissue Marker is explicitly designed for single-use only. Its sterile packaging and implantable nature make reuse unsafe and unsuitable for clinical practice, adhering to standard medical device guidelines for disposable implants.