NEU · Marker, Radiographic, Implantable

Device class

Class II

Regulation 878.4300

Total clearances

2020-05-06 → 2026-01-23

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4300

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Devicor Medical Products, Inc.	7	1	2026-01-23
Molli Surgical, Inc.	5	0	2024-09-26
Endomagnetics Ltd.,	2	0	2024-06-28
Merit Medical Systems, Inc.	2	1	2025-12-19
Breast-Med, Inc.	1	1	2025-12-12
Elucent Medical, Inc.	1	0	2024-12-20
Surgmark GmbH	1	0	2024-01-23
Bard Peripheral Vascular, Inc.	1	0	2025-03-24
Inrad, Inc.	1	0	2024-11-07
Merit Medical System, Inc.	1	0	2024-02-12
Carbon Medical Technologies, Inc.	1	0	2025-07-23
Health Beacons, Inc.	1	0	2020-05-06
C4 Imaging, LLC	1	0	2020-10-21
Somatex Medical Technologies GmbH	1	0	2021-02-18
Stryker Endoscopy	1	1	2025-12-31
View Point Medical	1	0	2024-09-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
76000	CPT	—	Low	Fluoroscopy or ultrasound with contrast injection; marker may be incidental to imaging
C1843	HCPCS	—	Low	Implantable marker devices may fall under this category

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-01-23	K253761	Devicor Medical Products, Inc.	HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
2025-12-31	K253888	Stryker Endoscopy	MOLLI 2 System
2025-12-19	K252892	Merit Medical Systems, Inc.	SCOUT MD Surgical Guidance System
2025-12-12	K251989	Breast-Med, Inc.	VizMark Preloaded Tissue Marker Device (VM-0001)
2025-07-23	K251748	Carbon Medical Technologies, Inc.	MammoSTAR Biopsy Site Identifier
2025-03-24	K243642	Bard Peripheral Vascular, Inc.	UltraCor Twirl Breast Tissue Marker
2024-12-20	K233639	Elucent Medical, Inc.	SmartClip Secure Soft Tissue Marker
2024-11-07	K240429	Inrad, Inc.	Trilogy Tissue Marker
2024-09-26	K234149	Molli Surgical, Inc.	MOLLI 2 System
2024-09-25	K240042	Molli Surgical, Inc.	MOLLI 2 System
2024-09-16	K241762	View Point Medical	OneMark
2024-07-10	K240527	Devicor Medical Products, Inc.	HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
2024-06-28	K232865	Endomagnetics Ltd.,	Magseed Pro Magnetic Marker System
2024-02-12	K231468	Merit Medical System, Inc.	SCOUT MD Surgical Guidance System
2024-01-23	K230836	Surgmark GmbH	SchurSign Tissue Marker
2024-01-12	K232615	Devicor Medical Products, Inc.	LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
2023-10-26	K231579	Molli Surgical, Inc.	MOLLI 2
2023-07-13	K221961	Devicor Medical Products, Inc.	HydroMARK Plus Breast Biopsy Site Marker
2023-01-21	K222832	Endomagnetics Ltd.,	Sentimag System
2023-01-18	K223107	Molli Surgical, Inc.	MOLLI 2
2022-04-21	K212158	Devicor Medical Products, Inc.	HydroMARK Breast Biopsy Site Marker
2022-04-08	K212882	Merit Medical Systems, Inc.	SCOUT BX Delivery System
2021-04-16	K210600	Molli Surgical, Inc.	MOLLI
2021-04-14	K210752	Devicor Medical Products, Inc.	HydroMARK Breast Biopsy Site Marker
2021-02-18	K201863	Somatex Medical Technologies GmbH	Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape