Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

K-Number: K230255 · 2023-03-28

ApplicantStryker Sustainability Solutions
Decision Date2023-03-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is a medical device manufactured by Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2023-03-28 under approval number K230255. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Stryker Sustainability Solutions. The 510(k) number is K230255.

When was Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 approved by the FDA?

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 received FDA 510(k) clearance on 2023-03-28, under approval number K230255.

What company makes Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is manufactured by Stryker Sustainability Solutions.

What is the FDA product code for Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

The FDA product code for Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is GEI.

Related Clinical Trials

NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING

Other Devices by Stryker Sustainability Solutions

K153415Reprocessed Stryker External Fixation Devices K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis K180499Reprocessed LigaSure Maryland Jaw Sealer/Divider K180451Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider

View all 24 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑