FDA 510(k)

EEA HEMORRHOID STAPLER & ACCESSORIES

K-Number: K083781 · 2009-02-04

ApplicantSurgical Devices, A Global Business Unit Covidien

Decision Date2009-02-04

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EEA HEMORRHOID STAPLER & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Devices, A Global Business Unit Covidien. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K083781. 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 EEA HEMORRHOID STAPLER & ACCESSORIES?

EEA HEMORRHOID STAPLER & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Surgical Devices, A Global Business Unit Covidien. The 510(k) number is K083781.

When did EEA HEMORRHOID STAPLER & ACCESSORIES receive FDA 510(k) clearance?

EEA HEMORRHOID STAPLER & ACCESSORIES received FDA 510(k) clearance on 2009-02-04, under 510(k) number K083781.

Who is the listed applicant for EEA HEMORRHOID STAPLER & ACCESSORIES?

The FDA 510(k) record lists Surgical Devices, A Global Business Unit Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEA HEMORRHOID STAPLER & ACCESSORIES?

The FDA product code for EEA HEMORRHOID STAPLER & ACCESSORIES 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.