HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE

Electrosurgical, Cutting & Coagulation & Accessories

GYRUS ENT L.L.C.

The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Hemostatix Thermal Scalpel System - #12 Blade.

Pre-market Notification Details

Device IDK002021
510k NumberK002021
Device Name:HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
ContactAlicia Farage
CorrespondentAlicia Farage
GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-03
Decision Date2000-08-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858736006076 K002021 000
00850007350260 K002021 000

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