FDA 510(k)

FRANKENMAN SURGICAL STAPLERS

K-Number: K101378 · 2010-06-29

ApplicantSuzhou Frankenman Medical Equipment Co., Ltd.

Decision Date2010-06-29

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FRANKENMAN SURGICAL STAPLERS is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Frankenman Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2010-06-29 under 510(k) number K101378. 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 FRANKENMAN SURGICAL STAPLERS?

FRANKENMAN SURGICAL STAPLERS is a medical device that received FDA 510(k) clearance on 2010-06-29. The listed applicant is Suzhou Frankenman Medical Equipment Co., Ltd.. The 510(k) number is K101378.

When did FRANKENMAN SURGICAL STAPLERS receive FDA 510(k) clearance?

FRANKENMAN SURGICAL STAPLERS received FDA 510(k) clearance on 2010-06-29, under 510(k) number K101378.

Who is the listed applicant for FRANKENMAN SURGICAL STAPLERS?

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

What is the FDA product code for FRANKENMAN SURGICAL STAPLERS?

The FDA product code for FRANKENMAN SURGICAL STAPLERS 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.