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FDA 510(k)

EasyMark Tissue Marker

K-Number: K183503 · 2019-10-17

ApplicantInrad, Inc.
Decision Date2019-10-17
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EasyMark Tissue Marker is a medical device manufactured by Inrad, Inc.. It received FDA 510(k) clearance on 2019-10-17 under approval number K183503. 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 EasyMark Tissue Marker?

EasyMark Tissue Marker is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Inrad, Inc.. The 510(k) number is K183503.

When was EasyMark Tissue Marker approved by the FDA?

EasyMark Tissue Marker received FDA 510(k) clearance on 2019-10-17, under approval number K183503.

What company makes EasyMark Tissue Marker?

EasyMark Tissue Marker is manufactured by Inrad, Inc..

What is the FDA product code for EasyMark Tissue Marker?

The FDA product code for EasyMark Tissue Marker is NEU.

Related Clinical Trials

NCT04968990 Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation RECRUITING NCT05593523 Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes ACTIVE_NOT_RECRUITING

Other Devices by Inrad, Inc.

K240429Trilogy Tissue Marker K243886ExpressCore Biopsy Device

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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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