Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4650](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4650) → FFE — System, Water Jet Catheter, Renal

# FFE · System, Water Jet Catheter, Renal

_Gastroenterology, Urology · 21 CFR 876.4650 · Class 2_

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

## Overview

- **Product Code:** FFE
- **Device Name:** System, Water Jet Catheter, Renal
- **Regulation:** [21 CFR 876.4650](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4650)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K971328](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFE/K971328.md) | OLYMPUS CD-6C-1 COAGULATION ELECTRODE | Olympus America, Inc. | Jul 1, 1997 | SESE |

## Top Applicants

- Olympus America, Inc. — 1 clearance

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

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