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)

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated

K-Number: K162047 · 2016-09-15

ApplicantCovidien
Decision Date2016-09-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-09-15 under approval number K162047. 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 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated?

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Covidien. The 510(k) number is K162047.

When was LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated approved by the FDA?

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated received FDA 510(k) clearance on 2016-09-15, under approval number K162047.

What company makes LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated?

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is manufactured by Covidien.

What is the FDA product code for LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated?

The FDA product code for LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is GEI.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT06929481 Screening With a DNA Blood Test to Address Colorectal Cancer Inequities ACTIVE_NOT_RECRUITING NCT05846893 Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT07586059 Continuous Renal Replacement Therapy, Impact on Intensive Care Unit Length of Stay NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05374187 Efficacy of Trigeminal Nerve Stimulation for ADHD COMPLETED

Related PubMed Literature

PMID: 42088337 Impact of Aneurysm Size and Flow Diverter Use on Outcomes After Endovascular Therapy of Unruptured Paraclinoid Aneurysms. Stroke (Hoboken, N.J.) (2026)

Other Devices by Covidien

K163055Reprocessed Kendall SCD Express Foot Cuff K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coated K160718Vital Sync Informatics Manager & Virtual Patient Monitoring Platform K162584VersaOne Bladeless Trocar K161804LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

View all 61 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.

↑