Atlas FDA

FFK

61 FDA 510(k) clearances · Product code

107 daysmedian time to decision
277 days90th percentile
61clearances measured

FDA profile

Official device name
Lithotriptor, Electro-Hydraulic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4480
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 10 · 2014: 9 · 2018: 18 · 2020: 39 · 2021: 22 · 2022: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (K243032)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-03-21
Electrohydraulic Lithotriptor (TCS-B3-II) (K242888)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-03-21
EL27-Compact; Sterile EHL-Probes (K230488)Walz Elektronik GmbH2023-08-31
URO-TOUCH 9 French Probe (K202813)Northgate Technologies, Inc.2021-06-14
Swiss LithoClast Trilogy (K191124)E.M.S Electro Medical Systems S.A2019-05-29
UreTron PF Series Probe (K162119)Med-Sonics Corp.2016-08-29
UreTron MultiProbe Lithotripter System (K160198)Med-Sonics Corp.2016-02-23
CYBERWAND STERILE PROBE SET (K132795)Cybersonics, Inc.2013-11-26
AUTOLITH TOUCH; URO TOUCH (K130368)Northgate Technologies, Inc.2013-11-15
SWISS LITHOBREAKER (K123038)E.M.S Electro Medical Systems S.A2013-01-16
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (K120303)Cybersonics, Inc.2012-06-05
URETRON MODEL URT (K111058)Med-Sonics Corp.2012-03-30
CYBERWAND LITHOTRIPTER (K102169)Cybersonics, Inc.2010-08-30
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR (K092033)Elmed USA2010-04-30
CYBERWAND STERILE PADS, MODEL: CW-RBPBX (K072422)Cybersonics, Inc.2007-10-24
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM (K062475)The Laryngeal Mask Co., Ltd.2007-05-09
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER (K052135)Cybersonics, Inc.2005-12-20
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX (K011911)Richard Wolf Medical Instruments Corp.2001-09-17
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (K011848)Circon Video2001-09-11
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445)Electro Medical Systems SA2001-08-24
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) (K011065)Richard Wolf Medical Instruments Corp.2001-05-09
MICROVASIVE LITHOTRIPTOR FLEXPROBE II (K002084)Boston Scientific Corp2000-07-19
KSEA CALCUSPLIT (K992114)Karl Storz Endoscopy1999-08-18
SWISS LITHOCLAST MULTIPURPOSE PROBE (K992251)Electro Medical Systems SA1999-07-27
ELECTRO MECHANICAL LITHOTRIPTOR (K990341)Northgate Technologies, Inc.1999-07-14
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) (K980492)Circon Acmi1998-11-17
KSEA CALCUSPLIT (K981233)KARL STORZ Endoscopy-America, Inc.1998-06-15
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (K974796)Medispec, Ltd.1998-03-12
MICROVASIVE LIPTHOTRIPSY PROBES (K973788)Boston Scientific Corp1998-01-21
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE (K974164)Medical Device Consultants, Inc.1997-12-18
EMS SWISS LITHOCLAST LITHOTRIPTER (K963285)Electro Medical Systems SA1997-02-13
SWISS LITHOCLAST LITHOTRIPTER (K951531)Electro Medical Systems SA1995-08-24
PULSE GUARD 3FR ELECTRODE (K944571)Northgate Technologies, Inc.1995-03-17
RIWOLITH 2280 PROBES (K931755)Richard Wolf Medical Instruments Corp.1994-04-15
EHL PULSE GENERATOR (K931779)Psi Medical Products, Inc.1994-02-15
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB (K920410)Psi Medical Products, Inc.1994-02-14
PULSE GUARD ELECTRODE (K925396)Northgate Technologies, Inc.1993-07-30
AUTOLITH-IEHL (K923822)Northgate Technologies, Inc.1993-01-28
SD-200IEHL(TM) (K914517)Northgate Technologies, Inc.1992-06-30
RIWOLITH 2280 (K913487)Richard Wolf Medical Instruments Corp.1992-02-05
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K914516)Northgate Technologies, Inc.1992-01-07
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K914515)Northgate Technologies, Inc.1992-01-07
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K914514)Northgate Technologies, Inc.1992-01-06
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K913955)Northgate Technologies, Inc.1991-11-29
LITHOTRIPTOR SYSTEM MODEL 27080 (K905553)Karl Storz GmbH & Co. (Kst)1991-06-04
1.9 FRENCH LITHOTRIPTER ELECTRODE (K903337)Northgate Research, Inc.1990-11-16
2.5 FRENCH LITHOTRIPTOR ELECTRODE (K894704)Northgate Research, Inc.1989-10-18
TECHNOMED PULSOLITH LASER SYSTEM (K895178)Teknomed, Inc.1989-10-06
MDL-1 LASERTRIPTER(TM) (K885255)Candela Laser Corp.1989-06-01
TECHNOMED PULSOLITH LASER SYSTEM (K890436)Teknomed, Inc.1989-03-23
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS (K883189)KARL STORZ Endoscopy-America, Inc.1989-02-13
MDL-1 LASERTRIPTER (K880503)Candela Laser Corp.1988-06-17
3F ELECTRODE (K864904)Northgate Research, Inc.1987-02-10
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR (K863642)Candela Corp.1986-12-03
5F ELECTRODE(LITHOTRIPTOR) (K852874)Northgate Research, Inc.1985-08-21
LITHOTRIPTOR ELECTRODE 4.5F (K834228)Monaghan Medical Corp.1984-05-25
COAXIAL ELECTRODE #300A (K832566)K-Med, Inc.1983-11-28
4.5 F LITHOTRIPTOR ELECTRODE (K830086)Monaghan Medical Corp.1983-02-09
LITHOTRIPTOR ELECTRODE 4.5F (K822585)Monaghan Medical Corp.1982-09-28
RIWOLITH 2135 (K822644)R. Wolf Medical Instruments Corp.1982-09-21
MODEL SD-1 DISINTEGRATOR (K802322)Northgate Research, Inc.1980-11-10

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Every clearance here is in the API, with alerts when new ones post.