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FDA 510(k)

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

K-Number: K181653 · 2018-09-18

ApplicantEthicon Endo-Surgery, LLC
Decision Date2018-09-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2018-09-18 under approval number K181653. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K181653.

When was Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed approved by the FDA?

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed received FDA 510(k) clearance on 2018-09-18, under approval number K181653.

What company makes Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

The FDA product code for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is GDW.

Related Clinical Trials

NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

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Related Devices (Code: GDW)

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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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