FDA 510(k)

Disposable Endoscopic Cutter Stapler and Cartridge

K-Nummer: K211197 · 2023-01-19

AntragstellerChangzhou Waston Medical Appliance Co., Ltd.

Entscheidungsdatum2023-01-19

ProduktcodeGDW

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Endoscopic Cutter Stapler and Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Waston Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K211197. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Disposable Endoscopic Cutter Stapler and Cartridge?

Disposable Endoscopic Cutter Stapler and Cartridge is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Changzhou Waston Medical Appliance Co., Ltd.. The 510(k) number is K211197.

When did Disposable Endoscopic Cutter Stapler and Cartridge receive FDA 510(k) clearance?

Disposable Endoscopic Cutter Stapler and Cartridge received FDA 510(k) clearance on 2023-01-19, under 510(k) number K211197.

Who is the listed applicant for Disposable Endoscopic Cutter Stapler and Cartridge?

The FDA 510(k) record lists Changzhou Waston Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge?

The FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge is GDW.

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Verwandte Geräte (Code: GDW)

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