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FDA 510(k)

EchoMark, EchoMark LP

K-Number: K180621 · 2018-06-06

ApplicantSonavex, Inc.
Decision Date2018-06-06
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EchoMark, EchoMark LP is the device name listed in this FDA 510(k) record. The listed applicant is Sonavex, Inc.. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180621. 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 EchoMark, EchoMark LP?

EchoMark, EchoMark LP is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Sonavex, Inc.. The 510(k) number is K180621.

When did EchoMark, EchoMark LP receive FDA 510(k) clearance?

EchoMark, EchoMark LP received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180621.

Who is the listed applicant for EchoMark, EchoMark LP?

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

What is the FDA product code for EchoMark, EchoMark LP?

The FDA product code for EchoMark, EchoMark LP 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.

NCT04896476Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous FistulaeCOMPLETED

Other records listing Sonavex, Inc. 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.

K243479EchoGuide (Version 1)K190039EchoSure Diagnostic Ultrasound System

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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