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EchoMark, EchoMark LP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180621

by Sonavex, Inc.

Identifiers

510(k) Number
K180621 FDA 510(k)
FDA Product Code
NEU FDA 510(k)

Classification

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

EchoMark and EchoMark LP are implantable radiographic markers classified as a bioresorbable polymeric implant. These devices are used for marking soft tissue sites in surgical patients to provide echogenic signals for ultrasound imaging.

This device has received FDA 510(k) clearance. It is categorized as a Class II medical device under regulation number 878.4300.

Frequently asked questions

What is the primary purpose of the EchoMark and EchoMark LP?

These devices are implantable radiographic markers used to mark specific soft tissue sites in surgical patients. They are designed to provide echogenic signals, which allow for clear visualization of the site during ultrasound imaging.

What material is used to manufacture these markers?

EchoMark and EchoMark LP are classified as bioresorbable polymeric implants. This means they are constructed from polymers intended to be absorbed by the body over time after the marker has served its clinical purpose.

What is the regulatory status of these devices?

The EchoMark and EchoMark LP have received FDA 510(k) clearance. They are categorized as Class II medical devices under regulation number 878.4300, which pertains to implantable radiographic markers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EchoMark - Sonavex, EchoMark, EchoMark LP (K180621) - FDA 510 (k), Sonavex, Inc. FDA 510 (k) Products - Latest 2025

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sonavex, Inc.

Sources (1)

  • FDA 510(k) K180621 24 fields · synced Sep 27, 2026