HOLOGIC, INC.

FDA Device Registration & Listing · Marlborough, MA, US · Registration 1222780

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1222780
FEI Number
1000120743
Entity Name
HOLOGIC, INC.
City/State/Country
Marlborough, MA, US
Establishment Address
250 Campus Dr, Marlborough, MA 01752, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
HOLOGIC, INC. (Owner Number: 9007676)
Owner / Operator Contact Address
250 Campus Drive, --, Marlborough, MA 01752, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K111692
PMA Number
N/A

All Registered Proprietary Names

MammoSite Cavity Evaluation Device MyoSure Reach BioZorb SP Marker Marker Wire Kit Fluent Pro Fluid Management System FirstCyte Contour Cover CoolSeal Mini; CoolSeal Generator Omni instrument tray BioZorb LP Marker Tumark Professional SecurMark Cellient MammoSite Office Accessory Kit Brevera Breast Biopsy System with Corlumina Imaging Technology NovaSure RF Controller NovaSure Device (Handpiece) NovaSure EndometrialAblation System ThinPrep Slides ThinPrep Arcless Slides FirstCyte Tapered&UltraSlim Dilator Sertera Introducer Set Celero Introducer Set MyoSure MyoSure Single Use Seals MyoSure Rod Lens Hysteroscope Trimark Mammosite accessory trays Genius Digital Diagnostics System with the Genius Cervical AI algorithm Eviva Stereotactic Breast Biopsy Device Eviva Adapters Myosure XL Hysteroscope Sanarus V2 Treatment System MammoSite ML Sanarus V2 Treatment System ConturaFlex MLB Catheter without Introducer ConturaFlex MLB Catheter with Introducer Contura Introducer and Split Sheath Contura MLB catheter with Introducer Contura MLB Catheter without Introducer Contura Accessory kit Fluent PreservCyt and CytoLyt SecurMark Sizer Set TruNode Gamma Probe System MammoSite RTS system 5-6 balloon MyoSure XL TRD for Fluent MammoSite Patient Care Kit ThinPrep Imaging System Stain Omni CoolSeal Trinity Contura Lumen Market Set, Single White Lumen marker, Single Black Lumen Marker, Compass Stainer SecurMark MammoSite Radiation Therapy System MammoSite 4-6 balloon MammoSite Cavity Evaluation Device Sizer Set GliaSite Radiation Therapy System Contura Cavity Maintenance Catheter with Introducer Celero ThinPrep filters Tumark Professional Q ATEC Console Tissue Filter Eviva ATEC Needle Guides Introducer Localization Set (ILS) ATEC Adapters MammoSite 4-5 balloon & Afterloader MammoSite Radiation Therapy System Tissue Removal Device SureSound INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Tumark Flex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2008-07-30
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2015-11-16
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2020-12-29
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 1992-07-14
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-07-26
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2024-07-26
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-04-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-25
MKQ Processor, Cervical Cytology Slide, Automated Unknown Class 3 N/A 2020-12-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2019-02-26
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2020-12-29
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2017-03-24
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2011-03-03
IDT Apparatus, Melting Point, Paraffin Pathology Class 1 864.3010 2008-05-23
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2008-04-09
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2017-04-06
MNB Device, Thermal Ablation, Endometrial Unknown Class 3 N/A 2008-04-09
KEW Slides, Microscope Pathology Class 1 864.3010 2008-04-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-01-21
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2016-06-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-05-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2011-02-17
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2011-02-17
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2007-11-05
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2010-06-17
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2017-12-08
QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm Pathology Class 2 864.3900 2024-02-20
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-04-16
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2012-09-19
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2021-03-04
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2009-09-02
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2021-03-04
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-06-28
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2018-08-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-08-03
LEA Preservative, Cytological Pathology Class 1 864.4010 2008-04-17
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2011-03-03
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2021-03-05
IZD Probe, Uptake, Nuclear Radiology Class 1 892.1320 2020-01-23
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2009-04-13
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-08-23
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2008-04-14
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2008-04-17
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-12-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-01-04
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-06-28
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2013-02-21
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2011-03-03
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2008-01-21
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2008-04-09
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2008-01-21
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2008-01-21
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-06-28
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2007-11-05
KET Filters, Cell Collection, Tissue Processing Pathology Class 1 864.3010 2008-04-17
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2017-03-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2003-01-16
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2008-01-21
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-05-14
MNM Reader, Cervical Cytology Slide, Automated Unknown Class 3 N/A 2017-01-04
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2008-04-09
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2014-03-12
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2017-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, 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
3013649990 HEALTH BEACONS, INC. Marlborough, MA, US
3012644426 ENDOMAGNETICS LTD Cambridge Cambridgeshire, GB
3005875675 GYNESONICS, INC. REDWOOD CITY, CA, US
3006330030 Hologic, Inc. Marlborough, MA, US
3010377594 BOLDER SURGICAL, LLC LOUISVILLE, CO, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16
K905706 Circon Acmi GYN-1500 HYSTEROSCOPIC INUFFLATOR 1991-02-28
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222780. Last updated year: 2026. Please use registration number 1222780 when referencing this establishment in official correspondence.
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