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) → FWH — Camera, Cine, Surgical, Without Audio

# FWH · Camera, Cine, Surgical, Without Audio

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

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

## Overview

- **Product Code:** FWH
- **Device Name:** Camera, Cine, Surgical, Without 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K884039](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWH/K884039.md) | MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 | Medical Dynamics, Inc. | Oct 13, 1988 | SESE |
| [K823516](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWH/K823516.md) | ESA CAMERA | Concept, Inc. | Dec 30, 1982 | SESE |

## Top Applicants

- Concept, Inc. — 1 clearance
- Medical Dynamics, Inc. — 1 clearance

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

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