Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

Device Code: 3989

Product Code(s): HIN

Device Classification Information

• Device Type ID: 3989
• Device Name: Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
• Regulation Description: Bipolar Endoscopic Coagulator-cutter And Accessories.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Obstetrics And Gynecology Devices Branch (OGDB)
• Submission Type: 510(k)
• CFR Regulation Number: 884.4150 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HIN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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: 3989
• Device: Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
• Product Code: HIN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Bipolar Endoscopic Coagulator-cutter And Accessories.
• CFR Regulation Number: 884.4150 [🔎]

Premarket Reviews
Manufacturer	Decision
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Material Separation	11
Break	5
Torn Material	4
Difficult To Remove	2
Device Operates Differently Than Expected	1
Insulation	1
Bent	1
Material Integrity Problem	1
Unintended Power Up	1
Arcing Of Electrodes	1
Physical Property Issue	1
No Apparent Adverse Event	1
Entrapment Of Device	1
Separation Failure	1
Device Handling Problem	1
Therapy Delivered To Incorrect Body Area	1
Electrical Shorting	1
Total Device Problems	35

TPLC Last Update: 2019-04-02 20:41:16