FDA 510(k)

Disposable Endoscopic Cutter Stapler and Cartridge

K-Number: K211197 · 2023-01-19

ApplicantChangzhou Waston Medical Appliance Co., Ltd.

Decision Date2023-01-19

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

Official Source

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