FDA 510(k)

GYRUS PLASMACISION LAPAROSCOPIC SPATULA

K-Number: K041633 · 2004-10-22

Decision Date2004-10-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS PLASMACISION LAPAROSCOPIC SPATULA is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical, Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K041633. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS PLASMACISION LAPAROSCOPIC SPATULA?

GYRUS PLASMACISION LAPAROSCOPIC SPATULA is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K041633.

When did GYRUS PLASMACISION LAPAROSCOPIC SPATULA receive FDA 510(k) clearance?

GYRUS PLASMACISION LAPAROSCOPIC SPATULA received FDA 510(k) clearance on 2004-10-22, under 510(k) number K041633.

Who is the listed applicant for GYRUS PLASMACISION LAPAROSCOPIC SPATULA?

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

What is the FDA product code for GYRUS PLASMACISION LAPAROSCOPIC SPATULA?

The FDA product code for GYRUS PLASMACISION LAPAROSCOPIC SPATULA is GEI.

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Other records listing Gyrus Medical, Inc. as applicant

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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.