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FDA 510(k)

MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS

K-Number: K080257 · 2008-05-22

ApplicantMedtronic Xomed, Inc.
Decision Date2008-05-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2008-05-22 under 510(k) number K080257. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS?

MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2008-05-22. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K080257.

When did MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS received FDA 510(k) clearance on 2008-05-22, under 510(k) number K080257.

Who is the listed applicant for MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS?

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

What is the FDA product code for MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS?

The FDA product code for MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS is GCJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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