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

SUTTER ELECTROSURGICAL CABLES

K Number: K073450 · Decision Mar 17, 2008
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
98

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Basic Information

Device Name
SUTTER ELECTROSURGICAL CABLES
K Number
K073450
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
Sutter Medizintechnik GmbH
Date Received
December 10, 2007
Decision Date
March 17, 2008
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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K192128 Sutter Arrowtip Monopolar Electrodes
K191732 Sutter RaVoR Bipolar Electrodes
K171869 Sutter CURIS RF Generator
K150959 Sutter Bipolar Forceps-Calvian
K131012 SUTTER BIPOLAR FORCEPS - SUPERGLISS