PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

Electrosurgical, Cutting & Coagulation & Accessories

GYRUS ACMI, INC.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pks Plasma Morcellator, Models 962000pk, 3620pk.

Pre-market Notification Details

Device IDK080093
510k NumberK080093
Device Name:PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
ContactTerrence E Sullivan
CorrespondentTerrence E Sullivan
GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-14
Decision Date2008-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925010710 K080093 000

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