Lithotriptor, Electro-hydraulic

Device Code: 1805

Product Code(s): FFK

Device Classification Information

• Device Type ID: 1805
• Device Name: Lithotriptor, Electro-hydraulic
• Regulation Description: Electrohydraulic Lithotriptor.
• 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: 876.4480 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FFK
• 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: 1805
• Device: Lithotriptor, Electro-hydraulic
• Product Code: FFK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electrohydraulic Lithotriptor.
• CFR Regulation Number: 876.4480 [🔎]

Premarket Reviews
Manufacturer	Decision
MED-SONICS CORP
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	12
Probe	8
Device Packaging Compromised	5
Adverse Event Without Identified Device Or Use Problem	3
Overheating Of Device	2
Detachment Of Device Or Device Component	1
Packaging Problem	1
Charred	1
Material Fragmentation	1
Device Emits Odor	1
Device Contamination With Chemical Or Other Material	1
Seal	1
Use Of Device Problem	1
Device Inoperable	1
Total Device Problems	39

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	May-02-2018
2	Northgate Technologies, Inc.	II	Nov-08-2017

TPLC Last Update: 2019-04-02 19:59:54