FEO · Lithotriptor, Ultrasonic
Gastroenterology, Urology · 21 CFR 876.4480 · Class 2
Overview
| Product Code | FEO |
|---|---|
| Device Name | Lithotriptor, Ultrasonic |
| Regulation | 21 CFR 876.4480 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Cleared Devices (14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | Oct 23, 2023 | SESE |
| K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Oct 9, 2018 | SESE |
| K181997 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Aug 30, 2018 | SESE |
| K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Jun 20, 2018 | SESE |
| K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Jan 10, 2018 | SESE |
| K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | Aug 21, 2017 | SESE |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | Nov 13, 2014 | SESE |
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Fibra Sonics, Inc. | Nov 22, 1999 | SESE |
| K973251 | KSEA CALCUSON | KARL STORZ Endoscopy-America, Inc. | Jun 22, 1998 | SESE |
| K920235 | ULTRASOUND GENERATOR MODLE 2270 | Richard Wolf Medical Instruments Corp. | Dec 7, 1992 | SESE |
| K873367 | OLYMPUS LUS ULTRASONIC LITHOTRIPTER | Olympus Corp. | Nov 30, 1987 | SESE |
| K850298 | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM | Cabot Medical Corp. | Mar 5, 1985 | SESE |
| K843101 | KARL STORZ 27086KC ULTRASONIC LITHOTRI | KARL STORZ Endoscopy-America, Inc. | Dec 11, 1984 | SESE |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Fibra Sonics, Inc. | Dec 11, 1984 | SESE |
Top Applicants
- E.M.S Electro Medical Systems S.A — 5 clearances
- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Fibra Sonics, Inc. — 2 clearances
- Cybersonics, Inc. — 2 clearances
- Richard Wolf Medical Instruments Corp. — 1 clearance
