Unit, Electrosurgical

Device Code: 1729

Product Code(s): FAR

Device Classification Information

• Device Type ID: 1729
• Device Name: Unit, Electrosurgical
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.4300 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FAR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03
  Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories

Total Product Life Cycle

• Device Type ID: 1729
• Device: Unit, Electrosurgical
• Product Code: FAR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• CFR Regulation Number: 876.4300 [🔎]

Device Problems
Insufficient Information	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:58:41