FEO — Lithotriptor, Ultrasonic Class II
FDA product code FEO covers "Lithotriptor, Ultrasonic", a Class II medical device regulated under 21 CFR 876.4480. Submissions are reviewed by the Gastroenterology, Urology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FEO
- Device Class
- Class II
- Regulation Number
- 876.4480
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230893 | e.m.s electro medical systems | Swiss LthoClast Trilogy | October 23, 2023 |
| K182490 | e.m.s electro medical systems | Swiss LithoClast Trilogy | October 9, 2018 |
| K181997 | e.m.s electro medical systems | Swiss LithoClast Trilogy | August 30, 2018 |
| K181364 | e.m.s electro medical systems | Swiss LithoClast Trilogy | June 20, 2018 |
| K173234 | e.m.s electro medical systems | Swiss LithoClast Trilogy | January 10, 2018 |
| K171024 | cybersonics | ShockPulse-SE Lithotripsy System | August 21, 2017 |
| K142428 | cybersonics | Shock Pulse-SE Lithotripsy System CYBERWAND II | November 13, 2014 |
| K993046 | fibra sonics | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | November 22, 1999 |
| K973251 | karl storz endoscopy-america | KSEA CALCUSON | June 22, 1998 |
| K920235 | richard wolf medical instruments | ULTRASOUND GENERATOR MODLE 2270 | December 7, 1992 |
| K873367 | olympus | OLYMPUS LUS ULTRASONIC LITHOTRIPTER | November 30, 1987 |
| K850298 | cabot medical | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM | March 5, 1985 |
| K843101 | karl storz endoscopy-america | KARL STORZ 27086KC ULTRASONIC LITHOTRI | December 11, 1984 |
| K842024 | fibra sonics | ULTRASONIC LITHOTRIPTOR 300A | December 11, 1984 |