FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FORCETRIAD ELECTROSURGICAL GENERATOR

K Number: K110268 · Decision May 31, 2011
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
2
Review Days
123

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Basic Information

Device Name
FORCETRIAD ELECTROSURGICAL GENERATOR
K Number
K110268
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Covidien Lp, Formerly Know AS Valleylab, A Divison
Date Received
January 28, 2011
Decision Date
May 31, 2011
Product Code
GEI
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

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Other Clearances by Covidien Lp, Formerly Know AS Valleylab, A Divison

K Number Device Name
K072687 VALLEYLAB MICROWAVE ABLATION GENERATOR