FFK — Lithotriptor, Electro-Hydraulic Class II
FDA Device Classification
Classification Details
- Product Code
- FFK
- Device Class
- Class II
- Regulation Number
- 876.4480
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242888 | guangzhou potent medical equipment joint-stock co | Electrohydraulic Lithotriptor (TCS-B3-II) | March 21, 2025 |
| K243032 | guangzhou potent medical equipment joint-stock co | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | March 21, 2025 |
| K230488 | walz elektronik | EL27-Compact; Sterile EHL-Probes | August 31, 2023 |
| K202813 | northgate technologies | URO-TOUCH 9 French Probe | June 14, 2021 |
| K191124 | e.m.s electro medical systems | Swiss LithoClast Trilogy | May 29, 2019 |
| K162119 | med-sonics | UreTron PF Series Probe | August 29, 2016 |
| K160198 | med-sonics | UreTron MultiProbe Lithotripter System | February 23, 2016 |
| K132795 | cybersonics | CYBERWAND STERILE PROBE SET | November 26, 2013 |
| K130368 | northgate technologies | AUTOLITH TOUCH; URO TOUCH | November 15, 2013 |
| K123038 | e.m.s electro medical systems | SWISS LITHOBREAKER | January 16, 2013 |
| K120303 | cybersonics | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | June 5, 2012 |
| K111058 | med-sonics | URETRON MODEL URT | March 30, 2012 |
| K102169 | cybersonics | CYBERWAND LITHOTRIPTER | August 30, 2010 |
| K092033 | elmed usa | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | April 30, 2010 |
| K072422 | cybersonics | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | October 24, 2007 |
| K062475 | laryngeal mask co | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | May 9, 2007 |
| K052135 | cybersonics | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | December 20, 2005 |
| K011911 | richard wolf medical instruments | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2 | September 17, 2001 |
| K011848 | circon video | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | September 11, 2001 |
| K012445 | electro medical systems | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | August 24, 2001 |