Sterigenics Costa Rica S.R.L.

FDA Device Registration & Listing · El Coyol Alajuela, CR · Registration 3010432890

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
3010432890
FEI Number
3010432890
Entity Name
Sterigenics Costa Rica S.R.L.
City/State/Country
El Coyol Alajuela, CR
Establishment Address
Zona Franca PROPARK, Calle Principal, Edificio 10, El Coyol Alajuela 20101, CR
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Sotera Health LLC (Owner Number: 10029425)
Owner / Operator Contact Address
2015 Spring Road, Suite 650, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stopcock 3 Way 3-Way Stopcock HBO Pass Through Headway Microcatheters SP1098 Entry Guide - 430022 da Vinci Xi Instrument Arm Drape Instrument Arm Drape Xi Instrument Arm Drape - 470015 Xi Column Drape - 470341 Suction conneting tube Aspiration Tubing 8MM Sureform 30 Reload, White - 48230W 8MM Sureform 30 Reload, Gray - 48230M 8MM Sureform 30 Reload, Blue - 48230B 8MM Sureform 30 Instrument, Curved Tip - 488530 8MM Sureform 30 Instrument, Straight Tip - 488430 Headway Microcatheters Microcatheter Headway Duo OverStitch™ Endoscopic Suturing System and Accessories Sofia Catheters ABLATION PROBE, MW ABLATION, IF1000 - 490130 Argon Angiography Drape OR Towel, Drapes Column Drape KP11827/250 IS4200 Arm 4 Proximal Drape - 470473 Xi Column Drape - 470341 IF1000 Vision Probe Bag - 490127 SP Camera Instrument Sheath - 430020 SP1098 Entry Guide - 430022 SP Drape - 430013 SP Instrument Sheath - 430012 SP Monopolar Scissors Tip - 430035 Guidewire Traxcess 14 Xi Suction/Irrigator - 480299 Sofia Catheters SureForm™ 45 (Stapler 45) Reload (White) - 48345W SureForm™ 45 (Stapler 45) Reload (Green) - 48345G SureForm™ 45 (Stapler 45) Reload (Black) - 48345T SureForm™ 45 (Stapler 45) Reload (Blue) - 48345B SureForm™ 45 (Stapler 45) Reload (Grey) - 48345M SureForm™ 45 (Stapler 45) Straight-Tip Instrument - 480445 FluidSmart Urology Tube Set FluidSmart Inflow Tube Set PAT OUTFLOW SET INFLOW SET FluidSmart Inflow Outflow Tube Set Headway Microcatheters Microcatheter Headway 17 Advanced Guidewire Traxcess 14EX Headway Microcatheters Microcatheter Headway 21 INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis MITRIS RESILIA Mitral Valve INSPIRIS 11500A (RESILIA Process) T4 PULLOVER TOGA, L T4 PULLOVER TOGA, L/XL T5 PULLOVER TOGA W/ PEELAWAY T4 ZIPPER TOGA W/INSIDE T4 ZIPPER TOGA, L T4 ZIPPER TOGA W/T3 CUT T4 ZIPPER TOGA, XL T4 HOOD W/BLUE STERILE WRAP T4 ZIPPER TOGA (L/XL) (10/PKG) T5 ZIPPER TOGA W/ PEELAWAY T4 ZIPPER TOGA, REGULAR T4 ZIPPER TOGA, S/M T4 HOOD EXTENDED LENGTH T5 HOOD W/ PEELAWAY FACE T4 PULLOVER TOGA, REGULAR T4 PULLOVER TOGA, S/M T4 PULLOVER TOGA, XL T4 HOOD (36/PKG) T4 HOOD W/PEEL POUCH Guidewire Traxcess Docking Wire Xi Harmonic ACE - 480275 Sofia Catheters Neptune E-SEP Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch Neptune E-SEP Smoke Evacuation Pencil, Coated, 70mm Blade, Rocker Switch Xi 8mm Synchroseal - 480440 Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Si Stapler Sheath - 410370 Xi Stapler 45 Reload (Blue) - 48645B Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G Burette Set Stapler Reload SureForm™ 45 (Blue) - 48245B SureForm™ 45 (Stapler 45) Curved-Tip Instrument - 480545 Si Harmonic ACE Insert - 400272 TREK OTW Dilatation Catheter NC TREK RX Dilatation Catheter NC TREK OTW Dilatation Catheter Mini Trek RX Dilatation Catheter TREK RX Dilatation Catheter MINI TREK II OTW Dilatation Catheter 23GBiopsy Needle,IF1000 - 490102 Vision Probe Adapter - 490101 Swivel Connector - 490108 19G Biopsy Needle,IF1000 - 490104 21G Biopsy Needle,IF1000 - 490103 FLYTE SURGICOOL HOOD W/PEELAWAY FLYTE SURGICOOL HOOD (28/CS) 0408-801-400 Flyte SurgiCool Hood 0408-801-500 Flyte SurgiCool Hood, Peelaway SP Monopolar Scissors Tip - 430035 SP Instrument Sheath - 430012 SP Camera Instrument Sheath - 430020 SP Drape - 430013 NC TREK OTW Dilatation Catheter ASSY,FENESTRATED BIPOLAR FORCEPS,SINGLE SITE,6-PAK (PN 428093-13) Xi Single Site Fenestrated Bipolar Forceps - 478093 Xi Single Site Bipolar Maryland - 478080 Xi Single-Site Cannula Seal - 478161 Xi Single-Site Port - 478065 Xi Stapler 30 Reload (Blue) - 48630B Xi Stapler 30 Reload (Green) - 48630G Xi Stapler 30 Reload (White) - 48630W Xi Stapler 30 Reload (Gray) - 48630M Si Cannula Seal - 400077 Si Cautery Spatula, A-Sure (5mm) - 400160

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2021-04-27
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2021-04-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2016-12-21
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2024-08-23
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2024-08-23
LWQ Heart-Valve, Mechanical Unknown Class 3 N/A 2024-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-08
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2013-02-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-08-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-07-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-12-21
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2020-05-29
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-11
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2012-11-01
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-07-08
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-07-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-12-06
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2016-12-20
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2017-07-05
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2021-04-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-07-12
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-07-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-07-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-08
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2016-02-25
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-02-25
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2021-02-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-12-21
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2017-07-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-14
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-07-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-07-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-07-12
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-08-23
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-02-09
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2025-07-08
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2025-07-08
HRX Arthroscope Orthopedic Class 2 888.1100 2025-07-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2016-12-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-12-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-12-06
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2024-08-23
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2018-03-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-08-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2021-02-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-07-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-07-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-07-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-08-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-02-21
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2025-02-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-02-09
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2017-07-05
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-05
QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Gastroenterology, Urology Class 2 876.5983 2026-05-13
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2016-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-02-25
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-02-25
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-02-25
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2016-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-07-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-07-18
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2020-06-01
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2016-12-21
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2024-08-23
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-02-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2017-08-10
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-09
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2013-07-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-20
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2021-02-26
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-02-26
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-07-05
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-02-02
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2021-02-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-02-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-21
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-06-20

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005914490 UNIDADE DE ESTERILIZACAO COTIA LTDA. Cotia Sao Paulo, BR
9680579 Sterigenics Radiation Technologies Canada, Inc PORT COQUITLAM British Columbia, CA
3008132411 Sterigenics Shanghai E Beam Ltd. Shanghai, CN
9616517 Sterigenics S. de R.L. de C.V. Tepeji del Rio de Ocampos Hidalgo, MX
3008328679 Sterigenics S. de R.L. de C.V. Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082659 Covidien Lp, Formerly Registered AS United States MODIFIED ENDO STICH 2008-09-19
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010432890. Last updated year: 2026. Please use registration number 3010432890 when referencing this establishment in official correspondence.
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