Hologic Surgical Products Costa Rica, S.R.L.

FDA Device Registration & Listing · El Coyol Alajuela, CR · Registration 3007200016

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
3007200016
FEI Number
3007200016
Entity Name
Hologic Surgical Products Costa Rica, S.R.L.
City/State/Country
El Coyol Alajuela, CR
Establishment Address
562 Parkway, Ave 0, Calle 0, Coyol Free Zone, El Coyol Alajuela 20102, CR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HOLOGIC, INC. (Owner Number: 9007676)
Owner / Operator Contact Address
250 Campus Drive, --, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

MammoSite Cavity Evaluation Device Sertera Introducer Set Celero Introducer Set MammoSite 4-5 balloon & Afterloader MammoSite Radiation Therapy System MyoSure XL TRD for Fluent CoolSeal Trinity Eviva Stereotactic Breast Biopsy Device Eviva Adapters Celero Sizer Set Omni Lok MammoSite RTS system 5-6 balloon MyoSure Sertera Biopsy Device MyoSure Reach TruNode Gamma Probe System Fluent SecurMark Tissue Removal Device Marker Wire Kit MammoSite Radiation Therapy System MammoSite 4-6 balloon MammoSite ML CoolSeal Reveal Fluent Pro Fluid Management System BioZorb Marker

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
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2016-06-03
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2008-01-21
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-01-04
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-04-16
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2007-11-05
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2021-03-05
QHZ Seal, Cervical, Mechanical, Unpowered Obstetrics/Gynecology Class 1 884.1690 2019-08-30
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-08-30
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2009-04-13
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-05-29
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2015-08-14
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2015-11-16
IZD Probe, Uptake, Nuclear Radiology Class 1 892.1320 2020-01-23
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
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2010-06-17
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2011-03-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-05-14
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 1992-07-14
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2008-01-21
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2009-09-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-13
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
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2020-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

Priscilla Aguilar Business: Hologic Email: priscilla.aguilar@hologic.com Phone: (978) 8263858

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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007200016. Last updated year: 2026. Please use registration number 3007200016 when referencing this establishment in official correspondence.
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