FDA 510(k)

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33

K-Number: K003277 · 2000-12-21

Decision Date2000-12-21

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 is the device name listed in this FDA 510(k) record. The listed applicant is Powermed, Inc.. It received FDA 510(k) clearance on 2000-12-21 under 510(k) number K003277. 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 SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33?

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 is a medical device that received FDA 510(k) clearance on 2000-12-21. The listed applicant is Powermed, Inc.. The 510(k) number is K003277.

When did SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 receive FDA 510(k) clearance?

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 received FDA 510(k) clearance on 2000-12-21, under 510(k) number K003277.

Who is the listed applicant for SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33?

The FDA 510(k) record lists Powermed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33?

The FDA product code for SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 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.