Stryker Sustainability Solutions - Chandler

FDA Device Registration & Listing · Chandler, AZ, US · Registration 3030153385

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
3030153385
FEI Number
3030153385
Entity Name
Stryker Sustainability Solutions - Chandler
City/State/Country
Chandler, AZ, US
Establishment Address
6635 W Frye Rd, Chandler, AZ 85226, US
Establishment Type(s)
Reprocess Single-Use Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K012344
PMA Number
N/A

All Registered Proprietary Names

Remanufactured LigaSure Exact Dissector, Without Nano-coating Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed Harmonic ACE+7, 5mm Diameter Shears with Advanced Hemostasis Reprocessed Endoscopic Trocars and Sleeves Reprocessed HARMONIC ACE+ 7, 5 Mm Diameter Shears With Advanced Hemostasis Reprocessed HARMONIC HAR1100 Shears Reprocessed Harmonic ACE Shears without adaptive tissue technology Reprocessed Masimo Pulse Oximeter Sensor Reprocessed RD Set Reprocessed Tourniquet Cuff Reprocessed MyoSure XL Tissue Removal Device Reprocessed MyoSure LITE Tissue Removal Device Reprocessed MyoSure XL Tissue Removal Device for Fluent Reprocessed MyoSure Tissue Removal Device Reprocessed MyoSure REACH Tissue Removal Device Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider Remanufactured LigaSure Exact Dissector Without Nano-coating Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed Masimo Pulse Oximeter Sensor Reprocessed Arthroscopic Cutters LXMJ44S Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Without Nano-coating 5mm LXMJ44L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm - LXMJ23S Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider One-step Sealing, Without Nano-coating 5mm - 23cm LXMJ23L Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider Latching Handle, Without Nano-coating 5mm - 23cm LXMJ37L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm - LXMJ37S Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Without Nano-coating 5mm Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers Reprocessed Trocars and Stability Sleeves Reprocessed Compression Sleeve Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Reprocessed Nellcor Pulse Oximeter Sensor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-27
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2022-04-11
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2017-02-23
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2017-02-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-08-07
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2020-08-07
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2021-04-01
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2021-04-01
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2024-02-26
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2024-02-26
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2014-05-02
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
DQA Oximeter Cardiovascular Class 2 870.2700 2025-08-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2025-08-20
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2007-06-20
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-10-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-27
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2022-05-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-11
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-11
HRX Arthroscope Orthopedic Class 2 888.1100 2010-02-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-06-19
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2026-06-19
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-01-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-01-09
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2014-01-06
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-12-06
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2023-04-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-20
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-04-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

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-0332-2022 Covidien Llc U
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030153385. Last updated year: 2026. Please use registration number 3030153385 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.