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FDA 510(k)

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers

K-Number: K211811 · 2022-03-03

ApplicantWuxi Beien Surgery Device Co., Ltd.
Decision Date2022-03-03
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K211811. 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 Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. The 510(k) number is K211811.

When did Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers receive FDA 510(k) clearance?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers received FDA 510(k) clearance on 2022-03-03, under 510(k) number K211811.

Who is the listed applicant for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA 510(k) record lists Wuxi Beien Surgery Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is GDW.

Related Clinical Trials

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.

NCT05360069Linear Stapler Versus Circular Stapler in EsophagojejunostomyRECRUITING

Related Devices (Code: GDW)

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.

K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part of Medtronic)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)Ethicon Endo-Surgery, LLCK250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLCK243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)Ethicon Endo-Surgery, LLCK241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLC

Official Source

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

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