SmartClip Soft Tissue Marker

FDA 510(k) K180640 · Elucent Medical, Inc.

Substantially Equivalent

510(k) numberK180640

Submission

Device name
SmartClip Soft Tissue Marker
Applicant
Elucent Medical, Inc.
Eden Prairie, MN, US
Received
March 12, 2018
Decision date
June 4, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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K252892SCOUT MD Surgical Guidance SystemNEU · Traditional Merit Medical Systems, Inc.12/19/2025SE
K251989VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional Breast-Med, Inc.12/12/2025SE
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K243642UltraCor™ Twirl™ Breast Tissue MarkerNEU · Traditional Bard Peripheral Vascular, Inc.03/24/2025SE
K233639SmartClip Secure Soft Tissue MarkerNEU · Traditional Elucent Medical, Inc.12/20/2024SE
K240429Trilogy Tissue MarkerNEU · Traditional Inrad, Inc.11/07/2024SE
K234149MOLLI 2 SystemNEU · Traditional Molli Surgical, Inc.09/26/2024SE
K240042MOLLI 2 SystemNEU · Traditional Molli Surgical, Inc.09/25/2024SE

More from Molli Surgical, Inc.

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K260565SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional 05/14/2026SE
K233639SmartClip Secure Soft Tissue MarkerNEU · Traditional 12/20/2024SE
K183400EnVisio Navigation SytemNEU · Traditional 03/22/2019SE

Questions and answers

When was SmartClip Soft Tissue Marker cleared by the FDA?

SmartClip Soft Tissue Marker (K180640) received a 510(k) decision of Substantially Equivalent on June 4, 2018, 84 days after the submission was received.

What is the product code of K180640?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.