Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4480](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4480) → FEO — Lithotriptor, Ultrasonic

# FEO · Lithotriptor, Ultrasonic

_Gastroenterology, Urology · 21 CFR 876.4480 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO

## Overview

- **Product Code:** FEO
- **Device Name:** Lithotriptor, Ultrasonic
- **Regulation:** [21 CFR 876.4480](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4480)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **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.”

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230893](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K230893.md) | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | Oct 23, 2023 | SESE |
| [K182490](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K182490.md) | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Oct 9, 2018 | SESE |
| [K181997](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K181997.md) | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Aug 30, 2018 | SESE |
| [K181364](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K181364.md) | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Jun 20, 2018 | SESE |
| [K173234](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K173234.md) | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | Jan 10, 2018 | SESE |
| [K171024](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K171024.md) | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | Aug 21, 2017 | SESE |
| [K142428](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K142428.md) | Shock Pulse-SE Lithotripsy System CYBERWAND II | Cybersonics, Inc. | Nov 13, 2014 | SESE |
| [K993046](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K993046.md) | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Fibra Sonics, Inc. | Nov 22, 1999 | SESE |
| [K973251](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K973251.md) | KSEA CALCUSON | KARL STORZ Endoscopy-America, Inc. | Jun 22, 1998 | SESE |
| [K920235](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K920235.md) | ULTRASOUND GENERATOR MODLE 2270 | Richard Wolf Medical Instruments Corp. | Dec 7, 1992 | SESE |
| [K873367](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K873367.md) | OLYMPUS LUS ULTRASONIC LITHOTRIPTER | Olympus Corp. | Nov 30, 1987 | SESE |
| [K850298](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K850298.md) | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM | Cabot Medical Corp. | Mar 5, 1985 | SESE |
| [K843101](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K843101.md) | KARL STORZ 27086KC ULTRASONIC LITHOTRI | KARL STORZ Endoscopy-America, Inc. | Dec 11, 1984 | SESE |
| [K842024](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO/K842024.md) | ULTRASONIC LITHOTRIPTOR 300A | Fibra Sonics, Inc. | Dec 11, 1984 | SESE |

## Top Applicants

- E.M.S Electro Medical Systems S.A — 5 clearances
- Cybersonics, Inc. — 2 clearances
- Fibra Sonics, Inc. — 2 clearances
- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Cabot Medical Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FEO)

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