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)

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

K-Number: K201280 · 2020-07-27

ApplicantEthicon Endo-Surgery, LLC
Decision Date2020-07-27
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 2020-07-27 under approval number K201280. 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 2020-07-27. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K201280.

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 2020-07-27, under approval number K201280.

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

Other Devices by Ethicon Endo-Surgery, LLC

K160554Enseal X1 Large Jaw Tissue Sealer K160128Endopath Electrosurgery Probe Plus II K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm K151136HARMONIC HOOK K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length K163523ECHELON CIRCULAR Powered Stapler

View all 33 devices →

Related Devices (Code: GDW)

K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and ReloadsVictor Medical Instruments Co., Ltd. K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler CartridgeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K162252FasTouch Fixation SystemVia Surgical , Ltd. K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.

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.

↑