Swiss Lithoclast Multipurpose Probe
FDA 510(k) K992251 · Electro Medical Systems SA
510(k) numberK992251
Submission
- Device name
- Swiss Lithoclast Multipurpose Probe
- Applicant
- Electro Medical Systems SA
North Attleboro, MA, US - Received
- July 6, 1999
- Decision date
- July 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K230488 | EL27-Compact; Sterile EHL-ProbesFFK · Traditional | Walz Elektronik GmbH | 08/31/2023SE |
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | Northgate Technologies, Inc. | 06/14/2021SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | E.M.S Electro Medical Systems S.A | 05/29/2019SE |
| K162119 | UreTron PF Series ProbeFFK · Special | Med-Sonics Corp. | 08/29/2016SE |
| K160198 | UreTron MultiProbe Lithotripter SystemFFK · Special | Med-Sonics Corp. | 02/23/2016SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | Cybersonics, Inc. | 11/26/2013SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | Northgate Technologies, Inc. | 11/15/2013SE |
| K123038 | Swiss LithobreakerFFK · Traditional | E.M.S Electro Medical Systems S.A | 01/16/2013SE |
More from E.M.S Electro Medical Systems S.A
| 510(k) | Device | Decision |
|---|---|---|
| K022328 | EMS Piezon Master 600ELC · Special | 08/13/2002SE |
| K022119 | EMS Air-Flow Handy 2 Dental HandpieceEFB · Special | 07/25/2002SE |
| K012445 | EMS Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra)FFK · Special | 08/24/2001SE |
| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | 10/04/2000SE |
| K991857 | Airflow HandyEFB · Traditional | 10/07/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | 12/16/1996SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Questions and answers
When was Swiss Lithoclast Multipurpose Probe cleared by the FDA?
Swiss Lithoclast Multipurpose Probe (K992251) received a 510(k) decision of Substantially Equivalent on July 27, 1999, 21 days after the submission was received.
What is the product code of K992251?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.