FDA 510(k)

Disposable Circular Stapler

K-Number: K172561 · 2017-12-05

ApplicantChangzhou Kangdi Medical Stapler Co., Ltd.

Decision Date2017-12-05

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Disposable Circular Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. It received FDA 510(k) clearance on 2017-12-05 under 510(k) number K172561. 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 Circular Stapler?

Disposable Circular Stapler is a medical device that received FDA 510(k) clearance on 2017-12-05. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. The 510(k) number is K172561.

When did Disposable Circular Stapler receive FDA 510(k) clearance?

Disposable Circular Stapler received FDA 510(k) clearance on 2017-12-05, under 510(k) number K172561.

Who is the listed applicant for Disposable Circular Stapler?

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

What is the FDA product code for Disposable Circular Stapler?

The FDA product code for Disposable Circular Stapler is GDW.

Other records listing Changzhou Kangdi Medical Stapler Co., Ltd. as applicant

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.

K172538Disposable Linear Stapler, Disposable Linear Cutter

Related Devices (Code: GDW)

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.