Swiss LithoClast Trilogy
FDA 510(k) K181997 · E.M.S Electro Medical Systems S.A
510(k) numberK181997
Submission
- Device name
- Swiss LithoClast Trilogy
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- July 26, 2018
- Decision date
- August 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEO – Lithotriptor, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230893 | Swiss LthoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 10/23/2023SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 10/09/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 01/10/2018SE |
| K171024 | ShockPulse-SE Lithotripsy SystemFEO · Traditional | Cybersonics, Inc. | 08/21/2017SE |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND IIFEO · Traditional | Cybersonics, Inc. | 11/13/2014SE |
| K993046 | Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model LS-2000FEO · Traditional | Fibra Sonics, Inc. | 11/22/1999SE |
| K973251 | Ksea CalcusonFEO · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/22/1998SE |
| K920235 | Ultrasound Generator Modle 2270FEO · Traditional | Richard Wolf Medical Instruments Corp. | 12/07/1992SE |
| K873367 | Olympus Lus Ultrasonic LithotripterFEO · Traditional | Olympus Corp. | 11/30/1987SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | 01/28/2026SE |
| K243279 | DOLORCLAST Focused Shock WavesPZL · Traditional | 08/13/2025SE |
| K230893 | Swiss LthoClast TrilogyFEO · Traditional | 10/23/2023SE |
| K220538 | DolorClast RadialISA · Traditional | 07/11/2022SE |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELC · Traditional | 10/20/2019SE |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LEDELC · Traditional | 08/16/2019SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | 05/29/2019SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | 01/10/2018SE |
Questions and answers
When was Swiss LithoClast Trilogy cleared by the FDA?
Swiss LithoClast Trilogy (K181997) received a 510(k) decision of Substantially Equivalent on August 30, 2018, 35 days after the submission was received.
What is the product code of K181997?
The FDA product code is FEO – Lithotriptor, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.