FDA 510(k)

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32

K-Number: K100386 · 2010-03-01

ApplicantChangzhou Waston Medical Appliance Co., Ltd.

Decision Date2010-03-01

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 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 2010-03-01 under 510(k) number K100386. 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, MODELS WHY-25, WHY-29. WHY 32?

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Changzhou Waston Medical Appliance Co., Ltd.. The 510(k) number is K100386.

When did DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 receive FDA 510(k) clearance?

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 received FDA 510(k) clearance on 2010-03-01, under 510(k) number K100386.

Who is the listed applicant for DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32?

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 CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32?

The FDA product code for DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 is GDW.

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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.