510(k) K142428
- Device
- Shock Pulse-SE Lithotripsy System CYBERWAND II
- Applicant
- CYBERSONICS, INC.
- 510(k) number
- K142428
- Product code
- FEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-13
- Date received
- 2014-08-29
- Regulation
- 876.4480
- Classification name
- Lithotriptor, Ultrasonic
- 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
- Jeff Vaitekunas
- Address
- 5340 Fryling Rd. Erie PA US 16510 16510
FDA Registration Numbers#
- 3006546082
- 3006617533
- 9610617
- 3010202439
- 9611102
- 2020550
- 1648564
- 2435119
- 8030987
- 2528981
- 3014342096
- 3011050570
- 3004096429
- 3009420598
- 2244478
- 3024021261
- 3010707607
- 2183744
- 9614434
- 1519132
- 3003790304
Source Documents#
Other 510(k) Records For Product Code FEO #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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