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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 the device name listed in this FDA 510(k) record. The listed applicant is Elucent Medical, Inc.. It received FDA 510(k) clearance on 2018-06-04 under 510(k) 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. The listed applicant is Elucent Medical, Inc.. The 510(k) number is K180640.

When did SmartClip Soft Tissue Marker receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartClip Soft Tissue Marker?

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

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

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

Other records listing Elucent Medical, 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.

K260565SmartClip Delivery Catheter (ADR-1715)K233639SmartClip Secure Soft Tissue MarkerK183400EnVisio Navigation Sytem

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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