Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → NVJ — Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

# NVJ · Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

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

## Overview

- **Product Code:** NVJ
- **Device Name:** Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042132](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVJ/K042132.md) | NOVASYS TRANSURETHRAL RF SYSTEM | Novasys Medical, Inc. | Dec 21, 2004 | SESE |

## Top Applicants

- Novasys Medical, Inc. — 1 clearance

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

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