← Product Code [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK) · K834228

# LITHOTRIPTOR ELECTRODE 4.5F (K834228)

_Monaghan Medical Corp. · FFK · May 25, 1984 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K834228

## Device Facts

- **Applicant:** Monaghan Medical Corp.
- **Product Code:** [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK.md)
- **Decision Date:** May 25, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4480
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K834228](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K834228)

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