FDA 510(k)

DISPOSABLE CIRCULAR STAPLER

K-Number: K131303 · 2013-06-11

ApplicantChangzhou City Zhiye Medical Devices Institute Co.

Decision Date2013-06-11

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 City Zhiye Medical Devices Institute Co.. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K131303. 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 2013-06-11. The listed applicant is Changzhou City Zhiye Medical Devices Institute Co.. The 510(k) number is K131303.

When did DISPOSABLE CIRCULAR STAPLER receive FDA 510(k) clearance?

DISPOSABLE CIRCULAR STAPLER received FDA 510(k) clearance on 2013-06-11, under 510(k) number K131303.

Who is the listed applicant for DISPOSABLE CIRCULAR STAPLER?

The FDA 510(k) record lists Changzhou City Zhiye Medical Devices Institute Co. 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.

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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.