Electrode, Flexible Suction Coagulator

Device Code: 1785

Product Code(s): FEH

Device Classification Information

• Device Type ID: 1785
• Device Name: Electrode, Flexible Suction Coagulator
• 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: FEH
• 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
• 9-53 ASTM F1992 -99 (Reapproved 2007)
  Standard Practice For Reprocessing Of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used With Flexible Endoscopes

Total Product Life Cycle

• Device Type ID: 1785
• Device: Electrode, Flexible Suction Coagulator
• Product Code: FEH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• CFR Regulation Number: 876.4300 [🔎]

Device Problems
Detachment Of Device Component	1
Device Issue	1
Device Operational Issue	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 19:59:35