SmartClip Secure Soft Tissue Marker

Q: What is the product code of K233639?

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

FDA 510(k) K233639 · Elucent Medical, Inc.

Substantially Equivalent

510(k) numberK233639

Submission

Device name: SmartClip Secure Soft Tissue Marker
Applicant: Elucent Medical, Inc.
Eden Prairie, MN, US
Received: November 13, 2023
Decision date: December 20, 2024
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

Other 510(k)s with product code NEU

510(k)	Device	Applicant	Decision
K253761	HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional	Devicor Medical Products, Inc.	01/23/2026SE
K253888	MOLLI 2 SystemNEU · Special	Stryker Endoscopy	12/31/2025SE
K252892	SCOUT MD Surgical Guidance SystemNEU · Traditional	Merit Medical Systems, Inc.	12/19/2025SE
K251989	VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional	Breast-Med, Inc.	12/12/2025SE
K251748	MammoSTAR Biopsy Site IdentifierNEU · Traditional	Carbon Medical Technologies, Inc.	07/23/2025SE
K243642	UltraCor Twirl Breast Tissue MarkerNEU · Traditional	Bard Peripheral Vascular, Inc.	03/24/2025SE
K240429	Trilogy Tissue MarkerNEU · Traditional	Inrad, Inc.	11/07/2024SE
K234149	MOLLI 2 SystemNEU · Traditional	Molli Surgical, Inc.	09/26/2024SE
K240042	MOLLI 2 SystemNEU · Traditional	Molli Surgical, Inc.	09/25/2024SE
K241762	OneMarkNEU · Traditional	View Point Medical	09/16/2024SE

More from View Point Medical

510(k)	Device	Decision
K260565	SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional	05/14/2026SE
K183400	EnVisio Navigation SytemNEU · Traditional	03/22/2019SE
K180640	SmartClip Soft Tissue MarkerNEU · Traditional	06/04/2018SE

Questions and answers

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

SmartClip Secure Soft Tissue Marker (K233639) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 403 days after the submission was received.

What is the product code of K233639?

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