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FDA 510(k)

LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated

K-Number: K181085 · 2018-06-21

ApplicantCovidien
Decision Date2018-06-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K181085. 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 Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated?

LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Covidien. The 510(k) number is K181085.

When did LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated receive FDA 510(k) clearance?

LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated received FDA 510(k) clearance on 2018-06-21, under 510(k) number K181085.

Who is the listed applicant for LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated?

The FDA product code for LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated is GEI.

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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