Chrysalis Intelligence · Sponsors · Devicor Medical Products, Inc.

Devicor Medical Products, Inc.

Cincinnati, OH, US · 10 510(k) clearances · 3 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

10

2020-08-18 → 2026-03-04

Last 12 months

2

Product codes

2

Most recent

2026-03-04

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NEU	Marker, Radiographic, Implantable	Class II	General, Plastic Surgery	7	2026-01-23
KNW	Instrument, Biopsy	Class II	Gastroenterology, Urology	3	2026-03-04

Safety

Recalls (3)

Class I (serious)

0

Risk of injury / death

Total recalls

3

Currently ongoing

1

Most recent

2026-04-24

Date	Severity	Status	Recall #	Product	Code	Reason
2026-04-24	Class II	Ongoing	Z-2239-2026	HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3	—	Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
2022-03-30	Class II	Terminated	Z-1124-2022	HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4	—	Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patie…
2020-09-07	Class III	Terminated	Z-0070-2021	Neoprobe GDS Control Unit, Model Number NPCU3	—	It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices …

Filings

All 510(k) clearances (10)

Date	K-number	Device	Code	Class	Specialty
2026-03-04	K260365	Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char	KNW	Class II	Gastroenterology, Urology
2026-01-23	K253761	HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)	NEU	Class II	General, Plastic Surgery
2024-10-29	K243095	Mammotome AutoCore Single Insertion Core Biopsy System	KNW	Class II	Gastroenterology, Urology
2024-07-10	K240527	HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)	NEU	Class II	General, Plastic Surgery
2024-01-12	K232615	LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))	NEU	Class II	General, Plastic Surgery
2023-07-13	K221961	HydroMARK Plus Breast Biopsy Site Marker	NEU	Class II	General, Plastic Surgery
2022-04-21	K212158	HydroMARK Breast Biopsy Site Marker	NEU	Class II	General, Plastic Surgery
2021-04-14	K210752	HydroMARK Breast Biopsy Site Marker	NEU	Class II	General, Plastic Surgery
2020-12-16	K203097	HydroMARK Breast Biopsy Site Markers	NEU	Class II	General, Plastic Surgery
2020-08-18	K202012	Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System	KNW	Class II	Gastroenterology, Urology