Search Results
Found 1 results
510(k) Data Aggregation
K Number
K220138Device Name
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
Manufacturer
LED SpA
Date Cleared
2022-10-05
(260 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LED SpA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SURTRON model devices (80D, 160, 200, FLASH 160 HF, 400 HP) are ElectroSurgical Units including monopolar and bipolar technology (excepts SURTRON 80D which delivers monopolar technology only). They are intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
Device Description
SURTRON model devices (80D, 160, 200, FLASH 160 HF, 400 HP) are ElectroSurgical Units including monopolar and bipolar technology (excepts SURTRON 80D which delivers monopolar technology only).
Ask a Question
Page 1 of 1