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FDA 510(k)

SmartClip Secure Soft Tissue Marker

K-Number: K233639 · 2024-12-20

ApplicantElucent Medical, Inc.
Decision Date2024-12-20
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SmartClip Secure Soft Tissue Marker is a medical device manufactured by Elucent Medical, Inc.. It received FDA 510(k) clearance on 2024-12-20 under approval number K233639. 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 SmartClip Secure Soft Tissue Marker?

SmartClip Secure Soft Tissue Marker is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Elucent Medical, Inc.. The 510(k) number is K233639.

When was SmartClip Secure Soft Tissue Marker approved by the FDA?

SmartClip Secure Soft Tissue Marker received FDA 510(k) clearance on 2024-12-20, under approval number K233639.

What company makes SmartClip Secure Soft Tissue Marker?

SmartClip Secure Soft Tissue Marker is manufactured by Elucent Medical, Inc..

What is the FDA product code for SmartClip Secure Soft Tissue Marker?

The FDA product code for SmartClip Secure Soft 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 NCT07530744 Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection NOT_YET_RECRUITING NCT05593523 Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes ACTIVE_NOT_RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Elucent Medical, Inc.

K180640SmartClip Soft Tissue Marker K183400EnVisio Navigation Sytem

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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