FDA 510(k)

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

K-Number: K080093 · 2008-05-02

Decision Date2008-05-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K080093. 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 PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK?

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K080093.

When did PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK receive FDA 510(k) clearance?

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080093.

Who is the listed applicant for PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK?

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

What is the FDA product code for PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK?

The FDA product code for PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK is GEI.

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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.