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Tissue Site Marking System

by Suros Surgical Systems, Inc.

510(k) K062528

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062528 Date26 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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 Site Marking System is a radiographic marker designed for permanent identification of soft tissue sites. It provides visible imaging confirmation under modalities such as ultrasound, X-ray, MRI, nuclear imaging, CT, and direct visualization to ensure accurate anatomical localization during surgical procedures.

This system is supplied as a single-use device and is intended for sterile application. It is classified as a Class II medical device under FDA regulations (878.4300) and has received 510(k) clearance for use in general and plastic surgery. Deployment is manual, and the markers are radiopaque to ensure visibility on radiographic imaging.

Other devices from Suros Surgical Systems, Inc.

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 imaging modalities can the Tissue Site Marking System be visualized with during surgical procedures?

    The Tissue Site Marking System is designed to be visible under multiple imaging modalities, including ultrasound, X-ray, MRI, nuclear imaging, CT scans, and direct visualization. This ensures accurate anatomical localization during surgery by providing radiographic confirmation of the marker’s placement.

  • Is the Tissue Site Marking System intended for reuse or is it single-use only?

    The Tissue Site Marking System is explicitly supplied as a single-use device. This design ensures sterility and reduces the risk of contamination or cross-infection, which is critical for surgical applications.

  • How is the Tissue Site Marking System deployed, and what makes it suitable for soft tissue identification?

    Deployment of the Tissue Site Marking System is manual, meaning it is placed directly by the surgeon or clinician during the procedure. Its radiopaque material ensures visibility on radiographic imaging, confirming the precise location of soft tissue sites under modalities like X-ray, MRI, or CT. This helps verify anatomical landmarks and improve surgical accuracy.

  • What storage requirements should be followed for the Tissue Site Marking System?

    Since the Tissue Site Marking System is supplied sterile and intended for single-use, it should be stored in its original packaging until use. The packaging is likely designed to maintain sterility, so avoid exposure to moisture, extreme temperatures, or contamination. Always follow the manufacturer’s instructions for proper storage to ensure device integrity.