Product code FEO
- Device name
- Lithotriptor, Ultrasonic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4480
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | 2023-10-23 |
| K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-10-09 |
| K181997 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-08-30 |
| K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-06-20 |
| K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-01-10 |
| K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | 2017-08-21 |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | 2014-11-13 |
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Fibra Sonics, Inc. | 1999-11-22 |
| K973251 | KSEA CALCUSON | KARL STORZ Endoscopy-America, Inc. | 1998-06-22 |
| K920235 | ULTRASOUND GENERATOR MODLE 2270 | Richard Wolf Medical Instruments Corp. | 1992-12-07 |
| K873367 | OLYMPUS LUS ULTRASONIC LITHOTRIPTER | Olympus Corp. | 1987-11-30 |
| K850298 | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM | Cabot Medical Corp. | 1985-03-05 |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Fibra Sonics, Inc. | 1984-12-11 |
| K843101 | KARL STORZ 27086KC ULTRASONIC LITHOTRI | KARL STORZ Endoscopy-America, Inc. | 1984-12-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00821925044180 | SHOCKPULSE | Gyrus ACMI, LLC | 2024-07-24 |
| 00821925044210 | SHOCKPULSE | Gyrus ACMI, LLC | 2024-07-24 |
| 00821925044227 | SHOCKPULSE | Gyrus ACMI, LLC | 2024-07-24 |
| 00821925044234 | SHOCKPULSE | Gyrus ACMI, LLC | 2024-07-24 |
| 00821925044241 | SHOCKPULSE | Gyrus ACMI, LLC | 2024-07-24 |
| 04048551090657 | n.a. | Karl Storz GmbH & Co. KG | 2018-07-21 |
| 07613353143534 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 07613353125707 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 04048551366547 | n.a. | Karl Storz GmbH & Co. KG | 2017-10-21 |
| 04048551080344 | n.a. | Karl Storz GmbH & Co. KG | 2017-10-20 |
| 04048551080368 | n.a. | Karl Storz GmbH & Co. KG | 2017-10-20 |
| 04048551395264 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551395073 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551394786 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551394533 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551394281 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551394199 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551394182 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551395271 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551085882 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551085868 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551085844 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551085820 | CALCUSON | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551083291 | CALCUSON | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551083277 | CALCUSON | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551079683 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551079645 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551079607 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551064498 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 00855279005122 | Lithotripsy Probe, Sterile Single Use ShockPulse-SE, 10.2 Fr (3.40mm) X 396mm | CYBERSONICS INC | 2016-04-30 |