FFK — Lithotriptor, Electro-Hydraulic Class II
FDA product code FFK covers "Lithotriptor, Electro-Hydraulic", a Class II medical device regulated under 21 CFR 876.4480. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K243032 | guangzhou potent medical equipment joint-stock co | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | March 21, 2025 |
| K242888 | guangzhou potent medical equipment joint-stock co | Electrohydraulic Lithotriptor (TCS-B3-II) | 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 |