SCOUT MD Surgical Guidance System

Q: What is the product code of K231468?

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

FDA 510(k) K231468 · Merit Medical System, Inc.

Substantially Equivalent

510(k) numberK231468

Submission

Device name: SCOUT MD Surgical Guidance System
Applicant: Merit Medical System, Inc.
South Jordan, UT, US
Received: May 22, 2023
Decision date: February 12, 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
K233639	SmartClip Secure Soft Tissue MarkerNEU · Traditional	Elucent Medical, Inc.	12/20/2024SE
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

More from Molli Surgical, Inc.

510(k)	Device	Decision
K252527	Surfacer Inside-Out Access Catheter SystemQJH · Special	09/10/2025SESU
K230636	Maestro MicrocatheterKRA · Special	03/30/2023SE
K212817	Merit Siege Vascular PlugKRD · Traditional	12/15/2021SE
K193571	Go2Wire Guide WireDQX · Traditional	04/08/2020SE

Questions and answers

When was SCOUT MD Surgical Guidance System cleared by the FDA?

SCOUT MD Surgical Guidance System (K231468) received a 510(k) decision of Substantially Equivalent on February 12, 2024, 266 days after the submission was received.

What is the product code of K231468?

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