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) → FXM — Camera, Still, Endoscopic

# FXM · Camera, Still, Endoscopic

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

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

## Overview

- **Product Code:** FXM
- **Device Name:** Camera, Still, Endoscopic
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K822167](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXM/K822167.md) | STILL ENDOSCOPIC CAMERAS | Kelleher Corp. | Aug 20, 1982 | SESE |

## Top Applicants

- Kelleher Corp. — 1 clearance

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

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