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Devicor Medical Products, Inc.

United States·US-MF-000003322

Last updated September 17, 2026

About

Mammotome and Sirius Medical announce Health Canada approval for the Pintuition® System, expanding access across the country.

From the manufacturer's own website. Source

Information

Country: United States
Address: 300, E. Business Way, Cincinnati, United States
Website: www.mammotome.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: John Cummings
EUDAMED SRN: US-MF-000003322
FDA FEI Number: 3008492462
DUNS Number: —

Catalogue (273)

Page 6 of 6

Device	Model / Reference	Registries	Class	Status
Nature's Bond 600 And Nature's Bond 603	K142168	FDA 510(k)	Class II	Active
HydroMARK Breast Biopsy Site Marker	K161021	FDA 510(k)	Class II	Active
HydroMARK Breast Biopsy Site Markers	K203097	FDA 510(k)	Class II	Active
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)	K240527	FDA 510(k)	Class II	Active
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)	K253761	FDA 510(k)	Class II	Active
HydroMARK Breast Biopsy Site Marker	K210752	FDA 510(k)	Class II	Active
Mammotome AutoCore™ Single Insertion Core Biopsy System	K243095	FDA 510(k)	Class II	Active
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))	K232615	FDA 510(k)	Class II	Active
HydroMARK Breast Biopsy Site Marker	K212158	FDA 510(k)	Class II	Active
HydroMARK Plus Breast Biopsy Site Marker	K221961	FDA 510(k)	Class II	Active
Mammotome revolve Dual Vacuum Assist Biopsy System	K152989	FDA 510(k)	Class II	Active
Mammotome Reolve Dual Vacuum Assisted Biopsy (vab) System	K123259	FDA 510(k)	Class II	Active
HydroMARK Breast Biopsy Site Markers	K170803	FDA 510(k)	Class II	Active
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System	K202012	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet	K153709	FDA 510(k)	Class II	Active
Extricare	K110078	FDA 510(k)	Class II	Active
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	K260365	FDA 510(k)	Class II	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEP10	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEI13	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEP10	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEP13	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEI10	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEH1	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

CEpartner4U NL

Importers

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Notified Bodies

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Authorities

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 24, 2026	Z-2239-2026	—	open, classified	Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Mar 30, 2022	Z-1124-2022	—	terminated	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 patient label incorrectly identifies the product as 4010-05-08-T3.
Sep 7, 2020	Z-0070-2021	—	terminated	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 distributed in China since 2011 is v6.01.
Feb 28, 2017	Z-1512-2017	—	terminated	The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
May 19, 2016	Z-2211-2016	—	terminated	A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.