Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160) → FWC — Camera, Television, Surgical, With Audio

# FWC · Camera, Television, Surgical, With Audio

_General, Plastic Surgery · 21 CFR 878.4160 · Class 1_

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

## Overview

- **Product Code:** FWC
- **Device Name:** Camera, Television, Surgical, With Audio
- **Regulation:** [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K890119](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWC/K890119.md) | BR-S601MU (SURGICAL VIDEO RECORDER) | Victor Co. of Japan, Ltd. C/O Jvc Corp. | Jan 24, 1989 | SESE |
| [K864381](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWC/K864381.md) | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | Luxtec Corp. | Dec 9, 1986 | SESE |
| [K854988](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWC/K854988.md) | KY-M280U SURGICAL CAMERA | Us Jvc Corp. | Jan 24, 1986 | SESE |

## Top Applicants

- Luxtec Corp. — 1 clearance
- Us Jvc Corp. — 1 clearance
- Victor Co. of Japan, Ltd. C/O Jvc Corp. — 1 clearance

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

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