Data / Medical devices / United States / Hologic, Inc.
Hologic, Inc.: FDA-registered device maker in Marlborough, MA, United States, 53 510(k) clearances and 3 PMA approvals
Hologic, Inc. is registered with the FDA (registration 1222780) in Marlborough, MA, United States. It lists 39 device types. The FDA files 53 510(k) clearances and 3 PMA approvals under its listings, the newest dated July 25, 2024. 16 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222780
- FEI number
- 1000120743
- Address
- 250 Campus Dr, Marlborough, MA, United States, 01752
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 14, 1992
- Registered through
- 2026
- Brand names listed
- ATEC, ATEC Adapters, ATEC Console, ATEC Introducers, ATEC handpiece, Acessa ProVu System, BioZorb LP Marker, BioZorb Marker and more
Devices it lists
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 |
| November 15, 2023 | K231012 | CoolSeal Trinity | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| September 7, 2021 | K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| May 6, 2021 | K203640 | CoolSeal Reveal | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| October 6, 2020 | K202114 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| September 26, 2019 | K192371 | BioZorb SP Marker | NEU | Substantially Equivalent | Focal Therapeutics | accessdata.fda.gov |
| August 29, 2019 | K191281 | Omni Hysteroscope, Omni Lok cervical seal | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| February 26, 2019 | K182052 | Omni Instrument Tray | KCT | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| December 6, 2018 | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181124 | Acessa ProVu System | HFG | Substantially Equivalent | Acessa Health, Inc. | accessdata.fda.gov |
| August 23, 2018 | K181974 | MyoSure XL Tissue Removal Device for Fluent | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| August 3, 2018 | K180825 | Fluent Fluid Management System | HIG | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| May 8, 2018 | K173901 | MyoSure MANUAL Tissue Removal Device | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| April 10, 2018 | K180233 | Eviva Stereotactic Guided Breast Biopsy System | KNW | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| September 20, 2017 | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| March 29, 2017 | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | KNW | 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 |
| August 26, 2015 | K152070 | BioZorb LP Marker | NEU | Substantially Equivalent | Focal Therapeutics | accessdata.fda.gov |
| August 14, 2015 | K150169 | Sertera Biopsy Device | KNW | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| June 29, 2015 | K143484 | BioZorb Marker | NEU | Substantially Equivalent | Focal Therapeutics | accessdata.fda.gov |
| February 8, 2013 | K121280 | MYOSURE INTRUMENT TRAY | KCT | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| October 17, 2012 | K120947 | THS INSTRUMENT TRAY | KCT | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| September 19, 2012 | K122563 | MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL | HIH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| April 6, 2012 | K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | OXO | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| February 28, 2012 | K113202 | TISSUE MARKER | NEU | Substantially Equivalent | Focal Therapeutics | accessdata.fda.gov |
| November 8, 2011 | K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| December 2, 2010 | K102768 | SECRMARK BIOPSY SITE MARKING SYSTEM | NEU | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| October 15, 2010 | K102686 | MYOSURE ROD LENS SCOPE SEALS | HIH | Substantially Equivalent | Interlace Medical, Inc. | accessdata.fda.gov |
| October 8, 2010 | K102608 | SECURMARK BIOPSY SITE MARKING SYSTEM | NEU | Substantially Equivalent | Suros Surgical Systems, Inc. A Hologic Company | accessdata.fda.gov |
| February 17, 2010 | K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| August 27, 2009 | K092405 | MAMMOSITE MULTI LUMEN | JAQ | Unknown | Hologic, Inc. | accessdata.fda.gov |
| August 21, 2009 | K091465 | MYOSURE ROD LENS HYSTEROSCOPE | HIH | Substantially Equivalent | Interlace Medical, Inc. | accessdata.fda.gov |
| August 19, 2009 | K092323 | CONTURA CAVITY MAINTENANCE CATHETER | JAQ | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| September 12, 2008 | K082264 | CONTURA LUMEN MARKER | JAQ | Unknown | Senorx, Inc. | accessdata.fda.gov |
| May 9, 2008 | K081179 | MAMMOSITE CAVITY EVALUATION DEVICE | JAQ | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| May 2, 2008 | K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | JAQ | Unknown | Senorx, Inc. | accessdata.fda.gov |
| April 30, 2008 | K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 | JAQ | Unknown | Senorx, Inc. | accessdata.fda.gov |
| March 19, 2008 | K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent | Somatex Medical Technologies GmbH | accessdata.fda.gov |
| February 7, 2008 | K073533 | SANARUS V2 TREATMENT SYSTEM | GEH | Substantially Equivalent | Sanarus Medical, Inc. | accessdata.fda.gov |
| January 4, 2008 | K072913 | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM | NEU | Substantially Equivalent | Suros Surgical Systems, Inc. A Hologic Company | accessdata.fda.gov |
| January 26, 2007 | K062528 | TISSUE SITE MARKING SYSTEM | NEU | Substantially Equivalent | Suros Surgical Systems, Inc. | accessdata.fda.gov |
| January 3, 2007 | K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | GEH | Substantially Equivalent | Sanarus Medical, Inc. | accessdata.fda.gov |
| October 6, 2004 | K042290 | VACUUM ASSISTED CORE BIOPSY DEVICE | KNW | Substantially Equivalent | Suros Surgical Systems, Inc. | accessdata.fda.gov |
| September 8, 2004 | K034021 | VACUUM ASSISTED CORE BIOPSY DEVICE | KNW | Substantially Equivalent | Suros Surgical Systems, Inc. | accessdata.fda.gov |
| August 26, 2004 | K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | Substantially Equivalent | Proxima Therapeutics, Inc. | accessdata.fda.gov |
| February 10, 2004 | K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | Substantially Equivalent | Proxima Therapeutics, Inc. | accessdata.fda.gov |
| May 21, 2003 | K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | Substantially Equivalent | Proxima Therapeutics, Inc. | accessdata.fda.gov |
| December 19, 2002 | K023450 | BIOPSY SITE TISSUE MARKER DEVICE | NEU | Substantially Equivalent | Promex, Inc. | accessdata.fda.gov |
| May 6, 2002 | K011690 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | Unknown | Proxima Therapeutics, Inc. | accessdata.fda.gov |
| July 24, 2001 | K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE | KNW | Substantially Equivalent | Promex, Inc. | accessdata.fda.gov |
| April 25, 2001 | K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 | KXK | Substantially Equivalent | Proxima Therapeutics, Inc. | accessdata.fda.gov |
| May 18, 2000 | K001098 | PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 | FMI | Substantially Equivalent | Pro. Duct Health, 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 8, 2026 | 98566 | Class II | Ongoing | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-0 | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | accessdata.fda.gov |
| March 23, 2026 | 98487 | Class II | Ongoing | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Sta | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. | accessdata.fda.gov |
| December 15, 2025 | 98172 | Class II | Ongoing | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | accessdata.fda.gov |
| December 12, 2025 | 98058 | Class II | Ongoing | ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | accessdata.fda.gov |
| January 15, 2025 | 96075 | Class II | Ongoing | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. | accessdata.fda.gov |
| October 10, 2024 | 95639 | Class I | Ongoing | BioZorb Marker. Radiographic soft tissue marker. | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. | accessdata.fda.gov |
| March 13, 2024 | 94359 | Class I | Ongoing | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F02 | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device | accessdata.fda.gov |
| May 2, 2023 | 92357 | Class II | Ongoing | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery | accessdata.fda.gov |
| October 10, 2022 | 95781 | Class II | Completed | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set | accessdata.fda.gov |
| August 9, 2022 | 90734 | Class II | Ongoing | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs comple | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date. | accessdata.fda.gov |
| October 28, 2016 | 75558 | Class II | Terminated | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound | Breach in sterile barrier compromising product sterility | accessdata.fda.gov |
| August 22, 2016 | 74989 | Class II | Terminated | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. | Incorrect label on the Sertera Biopsy Kit | accessdata.fda.gov |
| August 2, 2016 | 74839 | Class II | Terminated | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece) | Tip Breakage at the glue joint between the obturator body and tip | accessdata.fda.gov |
| May 31, 2016 | 74295 | Class II | Terminated | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy. | Cracks ATEC Canister Lids. | accessdata.fda.gov |
| January 24, 2014 | 67375 | Class II | Terminated | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intende | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1 | accessdata.fda.gov |
| January 29, 2003 | 25529 | Not yet classified | Terminated | ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001 | Microscope Slides contaminated with fungal material | accessdata.fda.gov |
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Updated May 12, 2026. 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.