Product Code: FFK FDA class 2 21 CFR 876.4480

Lithotriptor, Electro-Hydraulic

Gastroenterology, Urology

The Electro-Hydraulic Lithotriptor is a device that generates a hydraulic shock wave via an electrical spark discharge to fragment stones in the urinary tract or biliary system. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFK, regulated under 21 CFR 876.4480, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FFK in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FFK
Device Class: FDA class 2
Regulation Number: 876.4480
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243032	EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)	Mar 21, 2025	Substantially Equivalent	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
K242888	Electrohydraulic Lithotriptor (TCS-B3-II)	Mar 21, 2025	Substantially Equivalent	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
K230488	EL27-Compact; Sterile EHL-Probes	Aug 31, 2023	Substantially Equivalent	Walz Elektronik GmbH
K202813	URO-TOUCH 9 French Probe	Jun 14, 2021	Substantially Equivalent	Northgate Technologies, Inc.
K191124	Swiss LithoClast Trilogy	May 29, 2019	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K162119	UreTron PF Series Probe	Aug 29, 2016	Substantially Equivalent	Med-Sonics Corp.
K160198	UreTron MultiProbe Lithotripter System	Feb 23, 2016	Substantially Equivalent	Med-Sonics Corp.
K132795	CYBERWAND STERILE PROBE SET	Nov 26, 2013	Substantially Equivalent	Cybersonics, Inc.
K130368	AUTOLITH TOUCH; URO TOUCH	Nov 15, 2013	Substantially Equivalent	Northgate Technologies, Inc.
K123038	SWISS LITHOBREAKER	Jan 16, 2013	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K120303	CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM	Jun 05, 2012	Substantially Equivalent	Cybersonics, Inc.
K111058	URETRON MODEL URT	Mar 30, 2012	Substantially Equivalent	Med-Sonics Corp.
K102169	CYBERWAND LITHOTRIPTER	Aug 30, 2010	Substantially Equivalent	Cybersonics, Inc.
K092033	VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR	Apr 30, 2010	Substantially Equivalent	Elmed USA
K072422	CYBERWAND STERILE PADS, MODEL: CW-RBPBX	Oct 24, 2007	Substantially Equivalent	Cybersonics, Inc.
K062475	LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM	May 09, 2007	Substantially Equivalent	The Laryngeal Mask Co., Ltd.
K052135	CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER	Dec 20, 2005	Substantially Equivalent	Cybersonics, Inc.
K011911	SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX	Sep 17, 2001	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K011848	CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE	Sep 11, 2001	Substantially Equivalent	Circon Video
K012445	EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)	Aug 24, 2001	Substantially Equivalent	Electro Medical Systems SA
K011065	INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)	May 09, 2001	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K002084	MICROVASIVE LITHOTRIPTOR FLEXPROBE II	Jul 19, 2000	Substantially Equivalent	Boston Scientific Corp
K992114	KSEA CALCUSPLIT	Aug 18, 1999	Substantially Equivalent	Karl Storz Endoscopy
K992251	SWISS LITHOCLAST MULTIPURPOSE PROBE	Jul 27, 1999	Substantially Equivalent	Electro Medical Systems SA
K990341	ELECTRO MECHANICAL LITHOTRIPTOR	Jul 14, 1999	Substantially Equivalent	Northgate Technologies, Inc.
K980492	AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)	Nov 17, 1998	Substantially Equivalent	Circon Acmi
K981233	KSEA CALCUSPLIT	Jun 15, 1998	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K974796	LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER	Mar 12, 1998	Substantially Equivalent	Medispec, Ltd.
K973788	MICROVASIVE LIPTHOTRIPSY PROBES	Jan 21, 1998	Substantially Equivalent	Boston Scientific Corp
K974164	SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE	Dec 18, 1997	Substantially Equivalent	Medical Device Consultants, Inc.
K963285	EMS SWISS LITHOCLAST LITHOTRIPTER	Feb 13, 1997	Substantially Equivalent	Electro Medical Systems SA
K951531	SWISS LITHOCLAST LITHOTRIPTER	Aug 24, 1995	Substantially Equivalent	Electro Medical Systems SA
K944571	PULSE GUARD 3FR ELECTRODE	Mar 17, 1995	Substantially Equivalent	Northgate Technologies, Inc.
K931755	RIWOLITH 2280 PROBES	Apr 15, 1994	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K931779	EHL PULSE GENERATOR	Feb 15, 1994	Substantially Equivalent	Psi Medical Products, Inc.
K920410	EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB	Feb 14, 1994	Substantially Equivalent	Psi Medical Products, Inc.
K925396	PULSE GUARD ELECTRODE	Jul 30, 1993	Substantially Equivalent	Northgate Technologies, Inc.
K923822	AUTOLITH-IEHL	Jan 28, 1993	Substantially Equivalent	Northgate Technologies, Inc.
K914517	SD-200IEHL(TM)	Jun 30, 1992	Substantially Equivalent	Northgate Technologies, Inc.
K913487	RIWOLITH 2280	Feb 05, 1992	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K914516	9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION	Jan 07, 1992	Substantially Equivalent	Northgate Technologies, Inc.
K914515	3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION	Jan 07, 1992	Substantially Equivalent	Northgate Technologies, Inc.
K914514	1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION	Jan 06, 1992	Substantially Equivalent	Northgate Technologies, Inc.
K913955	1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION	Nov 29, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K905553	LITHOTRIPTOR SYSTEM MODEL 27080	Jun 04, 1991	Substantially Equivalent	Karl Storz GmbH & Co. (Kst)
K903337	1.9 FRENCH LITHOTRIPTER ELECTRODE	Nov 16, 1990	Substantially Equivalent	Northgate Research, Inc.
K894704	2.5 FRENCH LITHOTRIPTOR ELECTRODE	Oct 18, 1989	Substantially Equivalent	Northgate Research, Inc.
K895178	TECHNOMED PULSOLITH LASER SYSTEM	Oct 06, 1989	Substantially Equivalent	Teknomed, Inc.
K885255	MDL-1 LASERTRIPTER(TM)	Jun 01, 1989	Substantially Equivalent	Candela Laser Corp.
K890436	TECHNOMED PULSOLITH LASER SYSTEM	Mar 23, 1989	Substantially Equivalent	Teknomed, Inc.
K883189	MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS	Feb 13, 1989	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K880503	MDL-1 LASERTRIPTER	Jun 17, 1988	Substantially Equivalent	Candela Laser Corp.
K864904	3F ELECTRODE	Feb 10, 1987	Substantially Equivalent	Northgate Research, Inc.
K863642	CANDELA MODEL MDL-1 LASER LITHOTRIPTOR	Dec 03, 1986	Substantially Equivalent	Candela Corp.
K852874	5F ELECTRODE(LITHOTRIPTOR)	Aug 21, 1985	Substantially Equivalent	Northgate Research, Inc.
K834228	LITHOTRIPTOR ELECTRODE 4.5F	May 25, 1984	Substantially Equivalent	Monaghan Medical Corp.
K832566	COAXIAL ELECTRODE #300A	Nov 28, 1983	Substantially Equivalent	K-Med, Inc.
K830086	4.5 F LITHOTRIPTOR ELECTRODE	Feb 09, 1983	Substantially Equivalent	Monaghan Medical Corp.
K822585	LITHOTRIPTOR ELECTRODE 4.5F	Sep 28, 1982	Substantially Equivalent	Monaghan Medical Corp.
K822644	RIWOLITH 2135	Sep 21, 1982	Substantially Equivalent	R. Wolf Medical Instruments Corp.
K802322	MODEL SD-1 DISINTEGRATOR	Nov 10, 1980	Substantially Equivalent	Northgate Research, Inc.