510(k) K243032
- Device
- EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- 510(k) number
- K243032
- Product code
- FFK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-21
- Date received
- 2024-09-27
- Regulation
- 876.4480
- Classification name
- Lithotriptor, Electro-Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zhengzhou Li
- Address
- Rm. 603, Bldg. C2, Innovation Bldg., # 182 Science Ave., Huangpu District Guangzhou CN 510000 510000
FDA Registration Numbers#
- 1225687
- 9614434
- 3009217531
- 3005987240
- 3004096429
- 2528981
- 8030987
- 1519132
- 3002807616
- 1423662
- 2020550
- 1000121056
- 3009543101
- 3006546082
- 9611102
- 3010707607
- 1000161819
- 1314417
- 3010202439
- 3006617533
- 1418479
- 1820334
- 3005099803
- 3011050570
- 9681260
- 3034630389
- 1828132
- 2124215
- 1450997
- 9610617
- 1648564
- 3003790304
- 1825146
- 2183744
- 3014342096
- 2028632
Source Documents#
Other 510(k) Records For Product Code FFK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023-08-31 |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021-06-14 |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019-05-29 |
| K162119 | UreTron PF Series Probe | Med-Sonics Corp. | 2016-08-29 |
| K160198 | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | 2016-02-23 |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | 2013-11-26 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | 2013-11-15 |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | 2013-01-16 |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | 2012-06-05 |
| K111058 | URETRON MODEL URT | Med-Sonics Corp. | 2012-03-30 |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | 2010-08-30 |
| K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | 2010-04-30 |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | 2007-10-24 |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007-05-09 |