Data / Medical devices / United States / Hologic, Inc.

Hologic, Inc.: FDA-registered device maker in Marlborough, MA, United States, 7 510(k) clearances and 4 PMA approvals

Name: Hologic, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hologic, Inc. is registered with the FDA (registration 3006330030) in Marlborough, MA, United States. It lists 20 device types. The FDA files 7 510(k) clearances and 4 PMA approvals under its listings, the newest dated July 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006330030
Address: 445 Simarano Drive, Marlborough, MA, United States, 01752
Owner or operator: HOLOGIC, INC. (9007676)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 16, 2003
Registered through: 2026
Brand names listed: ATEC Adapters, ATEC Console, ATEC Introducers, ATEC handpiece, Acessa ProVu System, Cellient, Fluent, Fluent Pro Fluid Management System and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Melting Point, Paraffin	IDT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Coagulator, Laparoscopic, Unipolar (And Accessories)	HFG	2	Manufacturer	accessdata.fda.gov
Cytocentrifuge	IFB	1	Complaint file establishment	accessdata.fda.gov
Device, Thermal Ablation, Endometrial	MNB	3	Manufacturer	accessdata.fda.gov
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm	QYV	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Fetal Fibronectin	LKV	3	Manufacturer	accessdata.fda.gov
Filters, Cell Collection, Tissue Processing	KET	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Preservative, Cytological	LEA	1	Complaint file establishment	accessdata.fda.gov
Processor, Cervical Cytology Slide, Automated	MKQ	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reader, Cervical Cytology Slide, Automated	MNM	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Slides, Microscope	KEW	1	Complaint file establishment	accessdata.fda.gov
Stain, Papanicolau	HZJ	1	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Tracking, Soft Tissue, Intraoperative	OEW	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 25, 2024	K240886	Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)	HIG	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
January 31, 2024	DEN210035	Genius Digital Diagnostics System with the Genius Cervical AI algorithm	QYV	Unknown	Hologic, Inc.	accessdata.fda.gov
September 28, 2018	K181124	Acessa ProVu System	HFG	Substantially Equivalent	Acessa Health, Inc.	accessdata.fda.gov
August 3, 2018	K180825	Fluent Fluid Management System	HIG	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
November 13, 2015	K152723	Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	HIH	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
February 2, 2011	K103385	SECURVIEW DX DIAGNOSTIC WORKSTATION	LLZ	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
October 6, 2004	K042290	VACUUM ASSISTED CORE BIOPSY DEVICE	KNW	Substantially Equivalent	Suros Surgical Systems, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 6, 2003	P020002	THINPREP (R) IMAGING SYSTEM	MNM	9	June 2, 2015	accessdata.fda.gov
September 28, 2001	P010013	NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM	MNB	86	December 17, 2025	accessdata.fda.gov
May 20, 1996	P950039	THINPREP(R) PROCESSOR, MODEL TP 2000	MKQ	36	August 27, 2025	accessdata.fda.gov
September 21, 1995	P920048	FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)	LKV	26	August 26, 2026	accessdata.fda.gov

Compare with other makers

Updated July 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.