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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-229: AAMI / ANSI / IEC 60601-2-2:2009, medical electrical equipment - part 2-2: particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
CDRH Offices and Divisions associated with recognized standards:
Devices Affected:
Electrosurgical Devices
Processes Affected:
510(k), PMA, IDE, pre-IDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§878.4400 Apparatus, Electrosurgical Class 2 HAM
§878.4400 Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Class 2 NVJ
§878.4400 Electrode, Electrosurgical Class 2 JOS
§878.4400 Electrode, Gel, Electrosurgical Class 2 JOT
§878.4400 Electrosurgical Device Class 2 DWG
§878.4400 Electrosurgical Patient Return Electrode Class 2 ODR
§878.4400 Electrosurgical, Cutting & Coagulation & Accessories Class 2 GEI
§878.4400 Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Class 2 NUJ
§878.4400 Generator,Electrosurgical,Coagulation,Cancer Class 2 MUL
§878.4400 Low Energy Direct Current Thermal Ablation System Class 2 OAB
§878.4400 Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue Class 2 OCL
§878.4400 System, Ablation, Microwave And Accessories Class 2 NEY
§878.4400 System, Ablation, Ultrasound And Accessories Class 2 NTB
§878.4400 Unit, Electrosurgical Andcoagulation, With Accessories Class 2 BWA
Relevant Guidance:
Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff. Issued March 2014
FDA Technical Contact:
 Neil R. P. Ogden
  10903 New Hampshire Avenue Building 66, Room 1438
  Silver Spring MD 20993
  email: neil.ogden@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036