Snare, Flexible

Device Code: 1770

Product Code(s): FDI

Device Classification Information

• Device Type ID: 1770
• Device Name: Snare, Flexible
• 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: FDI
• 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: 1770
• Device: Snare, Flexible
• Product Code: FDI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• CFR Regulation Number: 876.4300 [🔎]

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
HANGZHOU AGS MEDTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDI-GLOBE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OVESCO ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Wire	335
Failure To Cut	229
Detachment Of Device Component	111
Break	96
Catheter	64
Entrapment Of Device	37
Failure To Deliver Energy	37
Device Contamination With Chemical Or Other Material	32
Positioning Problem	26
Cannula	26
Device Operates Differently Than Expected	17
Adverse Event Without Identified Device Or Use Problem	14
Detachment Of Device Or Device Component	11
Connector Pin	8
Overheating Of Device	4
Device-Device Incompatibility	4
Electrical /Electronic Property Problem	4
Retraction Problem	4
Difficult To Open Or Close	4
Material Deformation	3
Unsealed Device Packaging	3
Material Separation	3
Unintended Movement	2
Defective Device	2
Failure To Conduct	2
Material Split, Cut Or Torn	2
Activation, Positioning Or Separation Problem	2
Inappropriate Shock	2
Failure To Service	1
Human-Device Interface Problem	1
Energy Output To Patient Tissue Incorrect	1
Suction Problem	1
Electrode	1
Loss Of Or Failure To Bond	1
Difficult To Advance	1
Failure To Align	1
Component(s), Broken	1
Separation Failure	1
Total Device Problems	1094

Recalls
Manufacturer		Recall Class	Date Posted
1	US Endoscopy Group Inc	II	Oct-01-2015

TPLC Last Update: 2019-04-02 19:59:20