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) → FXR — Holder, Camera, Surgical

# FXR · Holder, Camera, Surgical

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

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

## Overview

- **Product Code:** FXR
- **Device Name:** Holder, Camera, Surgical
- **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 |
| --- | --- | --- | --- | --- |
| [K850122](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXR/K850122.md) | SONI-LOK SCOPE STABILIZER | Med Surg Designs, Inc. | Feb 21, 1985 | SESE |
| [K810303](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXR/K810303.md) | TELEVISION CAMERA HOLDER FOR SURGERY | The Anspach Effort, Inc. | Feb 26, 1981 | SESE |

## Top Applicants

- Med Surg Designs, Inc. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com