FDA Product Code
FDA Product Code FFK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4480
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | Traditional | PDF ↗ |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | Traditional | PDF ↗ |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023-08-31 | Traditional | PDF ↗ |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021-06-14 | Traditional | PDF ↗ |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019-05-29 | Special | PDF ↗ |
| K162119 | UreTron PF Series Probe | Med-Sonics Corp. | 2016-08-29 | Special | PDF ↗ |
| K160198 | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | 2016-02-23 | Special | PDF ↗ |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | 2013-11-26 | Special | PDF ↗ |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | 2013-11-15 | Traditional | PDF ↗ |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | 2013-01-16 | Traditional | PDF ↗ |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | 2012-06-05 | Abbreviated | PDF ↗ |
| K111058 | URETRON MODEL URT | Med-Sonics Corp. | 2012-03-30 | Abbreviated | PDF ↗ |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | 2010-08-30 | Special | PDF ↗ |
| K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | 2010-04-30 | Traditional | PDF ↗ |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | 2007-10-24 | Special | PDF ↗ |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007-05-09 | Traditional | PDF ↗ |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | 2005-12-20 | Abbreviated | PDF ↗ |
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | Richard Wolf Medical Instruments Corp. | 2001-09-17 | Traditional | PDF ↗ |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Circon Video | 2001-09-11 | Traditional | PDF ↗ |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Electro Medical Systems SA | 2001-08-24 | Special | PDF ↗ |
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) | Richard Wolf Medical Instruments Corp. | 2001-05-09 | Special | PDF ↗ |
| K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | Boston Scientific Corp | 2000-07-19 | Special | PDF ↗ |
| K992114 | KSEA CALCUSPLIT | Karl Storz Endoscopy | 1999-08-18 | Traditional | PDF ↗ |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Electro Medical Systems SA | 1999-07-27 | Special | PDF ↗ |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | Northgate Technologies, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | Circon Acmi | 1998-11-17 | Traditional | PDF ↗ |
| K981233 | KSEA CALCUSPLIT | KARL STORZ Endoscopy-America, Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | Medispec, Ltd. | 1998-03-12 | Traditional | PDF ↗ |
| K973788 | MICROVASIVE LIPTHOTRIPSY PROBES | Boston Scientific Corp | 1998-01-21 | Traditional | PDF ↗ |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | Medical Device Consultants, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | 1997-02-13 | Traditional | PDF ↗ |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | 1995-08-24 | Traditional | PDF ↗ |
| K944571 | PULSE GUARD 3FR ELECTRODE | Northgate Technologies, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K931755 | RIWOLITH 2280 PROBES | Richard Wolf Medical Instruments Corp. | 1994-04-15 | Traditional | PDF ↗ |
| K931779 | EHL PULSE GENERATOR | Psi Medical Products, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB | Psi Medical Products, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K925396 | PULSE GUARD ELECTRODE | Northgate Technologies, Inc. | 1993-07-30 | Traditional | PDF ↗ |
| K923822 | AUTOLITH-IEHL | Northgate Technologies, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K914517 | SD-200IEHL(TM) | Northgate Technologies, Inc. | 1992-06-30 | Traditional | PDF ↗ |
| K913487 | RIWOLITH 2280 | Richard Wolf Medical Instruments Corp. | 1992-02-05 | Traditional | PDF ↗ |
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-06 | Traditional | PDF ↗ |
| K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1991-11-29 | Traditional | PDF ↗ |
| K905553 | LITHOTRIPTOR SYSTEM MODEL 27080 | Karl Storz GmbH & Co. (Kst) | 1991-06-04 | Traditional | PDF ↗ |
| K903337 | 1.9 FRENCH LITHOTRIPTER ELECTRODE | Northgate Research, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K894704 | 2.5 FRENCH LITHOTRIPTOR ELECTRODE | Northgate Research, Inc. | 1989-10-18 | Traditional | PDF ↗ |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K885255 | MDL-1 LASERTRIPTER(TM) | Candela Laser Corp. | 1989-06-01 | Traditional | PDF ↗ |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K883189 | MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS | KARL STORZ Endoscopy-America, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K880503 | MDL-1 LASERTRIPTER | Candela Laser Corp. | 1988-06-17 | Traditional | PDF ↗ |
| K864904 | 3F ELECTRODE | Northgate Research, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K863642 | CANDELA MODEL MDL-1 LASER LITHOTRIPTOR | Candela Corp. | 1986-12-03 | Traditional | PDF ↗ |
| K852874 | 5F ELECTRODE(LITHOTRIPTOR) | Northgate Research, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K834228 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | 1984-05-25 | Traditional | PDF ↗ |
| K832566 | COAXIAL ELECTRODE #300A | K-Med, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K830086 | 4.5 F LITHOTRIPTOR ELECTRODE | Monaghan Medical Corp. | 1983-02-09 | Traditional | PDF ↗ |
| K822585 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K822644 | RIWOLITH 2135 | R. Wolf Medical Instruments Corp. | 1982-09-21 | Traditional | PDF ↗ |
| K802322 | MODEL SD-1 DISINTEGRATOR | Northgate Research, Inc. | 1980-11-10 | Traditional | PDF ↗ |
Product code FFK · Class II · Gastroenterology, Urology. Data: openFDA.