← Product Code [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK) · K914517

# SD-200IEHL(TM) (K914517)

_Northgate Technologies, Inc. · FFK · Jun 30, 1992 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K914517

## Device Facts

- **Applicant:** Northgate Technologies, Inc.
- **Product Code:** [FFK](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK.md)
- **Decision Date:** Jun 30, 1992
- **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/K914517](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K914517)

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