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) → MUK — Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

# MUK · Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

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

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

## Overview

- **Product Code:** MUK
- **Device Name:** Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K020952](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MUK/K020952.md) | SURX RF SYSTEM | Surx, Inc. | May 30, 2002 | SESE |
| [K020126](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MUK/K020126.md) | MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) | Surx, Inc. | Mar 15, 2002 | SESE |
| [K011190](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MUK/K011190.md) | SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) | Surx, Inc. | Jan 8, 2002 | SESE |

## Top Applicants

- Surx, Inc. — 3 clearances

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

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