Panels › Gastroenterology, Urology › Product code FFK · Class 2
Lithotriptor, Electro-Hydraulic
Regulation 876.4480
0510(k)s in 12 months (61 all time)
0recalls in 12 months (22 all time)
22recalls that name a 510(k)
Top companies in FFK
| Company | 510(k)s | Recalls |
|---|---|---|
| Northgate Technologies, Inc. | 11 | 6 |
| Cook Inc. | 0 | 7 |
| Cybersonics, Inc. | 5 | 0 |
| Northgate Research, Inc. | 5 | 0 |
| ACMI CORPORATION | 0 | 4 |
| Electro Medical Systems SA | 4 | 0 |
| Richard Wolf Medical Instruments Corp. | 4 | 0 |
| Boston Scientific Corp | 2 | 1 |
| E.M.S Electro Medical Systems S.A | 2 | 1 |
| Med-Sonics Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2025 | K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN | FFK |
| Mar 21, 2025 | K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN | FFK |
| Aug 31, 2023 | K230488 | EL27-Compact; Sterile EHL-Probes Walz Elektronik GmbH, DE | FFK |
| Jun 14, 2021 | K202813 | URO-TOUCH 9 French Probe Northgate Technologies, Inc. | FFK |
| May 29, 2019 | K191124 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FFK |
| Aug 29, 2016 | K162119 | UreTron PF Series Probe Med-Sonics Corp. | FFK |
| Feb 23, 2016 | K160198 | UreTron MultiProbe Lithotripter System Med-Sonics Corp. | FFK |
| Nov 26, 2013 | K132795 | CYBERWAND STERILE PROBE SET Cybersonics, Inc. | FFK |
| Nov 15, 2013 | K130368 | AUTOLITH TOUCH; URO TOUCH Northgate Technologies, Inc. | FFK |
| Jan 16, 2013 | K123038 | SWISS LITHOBREAKER E.M.S Electro Medical Systems S.A | FFK |
| Jun 5, 2012 | K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM Cybersonics, Inc. | FFK |
| Mar 30, 2012 | K111058 | URETRON MODEL URT Med-Sonics Corp. | FFK |
| Aug 30, 2010 | K102169 | CYBERWAND LITHOTRIPTER Cybersonics, Inc. | FFK |
| Apr 30, 2010 | K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR Elmed USA | FFK |
| Oct 24, 2007 | K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX Cybersonics, Inc. | FFK |
| May 9, 2007 | K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM The Laryngeal Mask Co., Ltd. | FFK |
| Dec 20, 2005 | K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER Cybersonics, Inc. | FFK |
| Sep 17, 2001 | K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX Richard Wolf Medical Instruments Corp. | FFK |
| Sep 11, 2001 | K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE Circon Video | FFK |
| Aug 24, 2001 | K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA | FFK |
| May 9, 2001 | K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) Richard Wolf Medical Instruments Corp. | FFK |
| Jul 19, 2000 | K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II Boston Scientific Corp | FFK |
| Aug 18, 1999 | K992114 | KSEA CALCUSPLIT Karl Storz Endoscopy | FFK |
| Jul 27, 1999 | K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE Electro Medical Systems SA | FFK |
| Jul 14, 1999 | K990341 | ELECTRO MECHANICAL LITHOTRIPTOR Northgate Technologies, Inc. | FFK |
| Nov 17, 1998 | K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) Circon Acmi | FFK |
| Jun 15, 1998 | K981233 | KSEA CALCUSPLIT KARL STORZ Endoscopy-America, Inc. | FFK |
| Mar 12, 1998 | K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER Medispec, Ltd. | FFK |
| Jan 21, 1998 | K973788 | MICROVASIVE LIPTHOTRIPSY PROBES Boston Scientific Corp | FFK |
| Dec 18, 1997 | K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE Medical Device Consultants, Inc. | FFK |
| Feb 13, 1997 | K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA | FFK |
| Aug 24, 1995 | K951531 | SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA | FFK |
| Mar 17, 1995 | K944571 | PULSE GUARD 3FR ELECTRODE Northgate Technologies, Inc. | FFK |
| Apr 15, 1994 | K931755 | RIWOLITH 2280 PROBES Richard Wolf Medical Instruments Corp. | FFK |
| Feb 15, 1994 | K931779 | EHL PULSE GENERATOR Psi Medical Products, Inc. | FFK |
| Feb 14, 1994 | K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB Psi Medical Products, Inc. | FFK |
| Jul 30, 1993 | K925396 | PULSE GUARD ELECTRODE Northgate Technologies, Inc. | FFK |
| Jan 28, 1993 | K923822 | AUTOLITH-IEHL Northgate Technologies, Inc. | FFK |
| Jun 30, 1992 | K914517 | SD-200IEHL(TM) Northgate Technologies, Inc. | FFK |
| Feb 5, 1992 | K913487 | RIWOLITH 2280 Richard Wolf Medical Instruments Corp. | FFK |
| Jan 7, 1992 | K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Jan 7, 1992 | K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Jan 6, 1992 | K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Nov 29, 1991 | K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Jun 4, 1991 | K905553 | LITHOTRIPTOR SYSTEM MODEL 27080 Karl Storz GmbH & Co. (Kst) | FFK |
| Nov 16, 1990 | K903337 | 1.9 FRENCH LITHOTRIPTER ELECTRODE Northgate Research, Inc. | FFK |
| Oct 18, 1989 | K894704 | 2.5 FRENCH LITHOTRIPTOR ELECTRODE Northgate Research, Inc. | FFK |
| Oct 6, 1989 | K895178 | TECHNOMED PULSOLITH LASER SYSTEM Teknomed, Inc. | FFK |
| Jun 1, 1989 | K885255 | MDL-1 LASERTRIPTER(TM) Candela Laser Corp. | FFK |
| Mar 23, 1989 | K890436 | TECHNOMED PULSOLITH LASER SYSTEM Teknomed, Inc. | FFK |
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