Data / Medical devices / Costa Rica / Hologic Surgical Products Costa Rica, S.R.L.
Hologic Surgical Products Costa Rica, S.R.L.: FDA-registered device maker in El Coyol Alajuela, Costa Rica, 28 510(k) clearances and 1 PMA approval
Hologic Surgical Products Costa Rica, S.R.L. is registered with the FDA (registration 3007200016) in El Coyol Alajuela, Costa Rica. It lists 13 device types. The FDA files 28 510(k) clearances and 1 PMA approval under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007200016
- Address
- 562 Parkway, Ave 0, Calle 0 Coyol Free Zone, El Coyol Alajuela, Costa Rica, 20102
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 14, 1992
- Registered through
- 2027
- Brand names listed
- ATEC Adapters, ATEC Console, ATEC Introducers, ATEC handpiece, BioZorb LP Marker, BioZorb Marker, Brevera Breast Biopsy System with Corlumina Imaging Technology, Celero and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Thermal Ablation, Endometrial | MNB | 3 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Hysteroscopic | HIG | 2 | Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Manufacturer | accessdata.fda.gov |
| Seal, Cervical, Mechanical, Unpowered | QHZ | 1 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | 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 |
| 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 |
| August 29, 2019 | K191281 | Omni Hysteroscope, Omni Lok cervical seal | HIH | Substantially Equivalent | Hologic, 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 |
| 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 |
| August 27, 2009 | K092405 | MAMMOSITE MULTI LUMEN | JAQ | Unknown | Hologic, Inc. | accessdata.fda.gov |
| May 9, 2008 | K081179 | MAMMOSITE CAVITY EVALUATION DEVICE | JAQ | Substantially Equivalent | Hologic, 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 |
| 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 |
| 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 |
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 |
|---|---|---|---|---|---|---|
| September 28, 2001 | P010013 | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM | MNB | 86 | December 17, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Hysteroscope Accessories
- All makers of Instrument, Biopsy
- All makers of Guide, Needle, Surgical
- All makers of Marker, Radiographic, Implantable
- All makers of Device, Thermal Ablation, Endometrial
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 17, 2025. 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.