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FDA 510(k)

SmartClip Soft Tissue Marker

K-Number: K180640 · 2018-06-04

ApplicantElucent Medical, Inc.
Decision Date2018-06-04
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SmartClip Soft Tissue Marker is a medical device manufactured by Elucent Medical, Inc.. It received FDA 510(k) clearance on 2018-06-04 under approval number K180640. 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 Soft Tissue Marker?

SmartClip Soft Tissue Marker is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Elucent Medical, Inc.. The 510(k) number is K180640.

When was SmartClip Soft Tissue Marker approved by the FDA?

SmartClip Soft Tissue Marker received FDA 510(k) clearance on 2018-06-04, under approval number K180640.

What company makes SmartClip Soft Tissue Marker?

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

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

The FDA product code for SmartClip Soft Tissue Marker is NEU.

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Other Devices by Elucent Medical, Inc.

K183400EnVisio Navigation Sytem K233639SmartClip Secure Soft Tissue Marker

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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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