Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008492462

FEI Number

3008492462

Entity Name

DEVICOR MEDICAL PRODUCTS, INC.

City/State/Country

Cincinnati, OH, US

Establishment Address

300 E-Business Way, Fifth Floor, Cincinnati, OH 45241, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Devicor Medical Products, Inc. (Owner Number: 10033297)

Owner / Operator Contact Address

300 E-Business Way, Fifth Floor, Cincinnati, OH 45241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991980

PMA Number

N/A

All Registered Proprietary Names

Mammotome® Biopsy System HydroMARK Plus Breast Biopsy Site Marker Mammotome AutoCore Single Insertion Core Biopsy System Mammotome® Probe and Housing Mammotome revolve HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) Mammotome CoreVision sample tray Mammotome® EX Hand Held System Mammotome® System Disposable Probe HydroMARK Plus Mammotome revolve EX Mammotome elite Biopsy System HydroMark Breast Biopsy Site Marker MammoMark¿ MR Biopsy Identifier CorMARK¿ Biopsy Identifier MammoMark¿ Biopsy Identifier LumiMARK Biopsy Site Marker Mammotome® MR Biopsy System Mammotome® Hand Held System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-07-30
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-07-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-11-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-07-30
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-16
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-08-09
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2022-03-30
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-07-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-07-30
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-02-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-08-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-08-12
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-04-22
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-07-30
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2010-07-30
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-01-30
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-07-30
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-07-30

Official Correspondent

Katrine Austin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Devicor Medical Products, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010339638	Devicor Medical Products, Inc. Warehouse/Distribution/Service Center	Blue Ash, OH, US
3008992312	Devicor Medical Products de Mexico S de RL de CV	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008492462. Last updated year: 2026. Please use registration number 3008492462 when referencing this establishment in official correspondence.