ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
FDA 510(k) clearance K850298 · decided 1985-03-05
Clearance details
- K-number
- K850298
- Device name
- ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
- Applicant
- Cabot Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-24
- Decision date
- 1985-03-05
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- FEO
- Device class
- 2
- Regulation number
- 876.4480
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Swiss LthoClast Trilogy (K230893) | E.M.S Electro Medical Systems S.A | 2023-10-23 |
| Swiss LithoClast Trilogy (K182490) | E.M.S Electro Medical Systems S.A | 2018-10-09 |
| Swiss LithoClast Trilogy (K181997) | E.M.S Electro Medical Systems S.A | 2018-08-30 |
| Swiss LithoClast Trilogy (K181364) | E.M.S Electro Medical Systems S.A | 2018-06-20 |
| Swiss LithoClast Trilogy (K173234) | E.M.S Electro Medical Systems S.A | 2018-01-10 |
| ShockPulse-SE Lithotripsy System (K171024) | Cybersonics, Inc. | 2017-08-21 |
| Shock Pulse-SE Lithotripsy System CYBERWAND II (K142428) | Cybersonics, Inc. | 2014-11-13 |
| FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (K993046) | Fibra Sonics, Inc. | 1999-11-22 |
| KSEA CALCUSON (K973251) | KARL STORZ Endoscopy-America, Inc. | 1998-06-22 |
| ULTRASOUND GENERATOR MODLE 2270 (K920235) | Richard Wolf Medical Instruments Corp. | 1992-12-07 |
| OLYMPUS LUS ULTRASONIC LITHOTRIPTER (K873367) | Olympus Corp. | 1987-11-30 |
| ULTRASONIC LITHOTRIPTOR 300A (K842024) | Fibra Sonics, Inc. | 1984-12-11 |
Recalls involving this device
No recalls on record reference this clearance.