FDA 510(k)

ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS

K-Number: K130738 · 2013-12-13

ApplicantNanjing Maidixin Medical Device Co., Ltd.

Decision Date2013-12-13

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Maidixin Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2013-12-13 under 510(k) number K130738. 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 ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS?

ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Nanjing Maidixin Medical Device Co., Ltd.. The 510(k) number is K130738.

When did ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS receive FDA 510(k) clearance?

ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS received FDA 510(k) clearance on 2013-12-13, under 510(k) number K130738.

Who is the listed applicant for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS?

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

What is the FDA product code for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS?

The FDA product code for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS is GDW.

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Official Source

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