UreTron MultiProbe Lithotripter System
FDA 510(k) clearance K160198 · decided 2016-02-23
Clearance details
- K-number
- K160198
- Device name
- UreTron MultiProbe Lithotripter System
- Applicant
- Med-Sonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2016-01-28
- Decision date
- 2016-02-23
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- FFK
- Device class
- 2
- Regulation number
- 876.4480
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Erie, PA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 GmbH | 2023-08-31 |
| URO-TOUCH 9 French Probe (K202813) | Northgate Technologies, Inc. | 2021-06-14 |
| Swiss LithoClast Trilogy (K191124) | E.M.S Electro Medical Systems S.A | 2019-05-29 |
| UreTron PF Series Probe (K162119) | Med-Sonics Corp. | 2016-08-29 |
| 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.A | 2013-01-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.