Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart B — Diagnostic Devices](/submissions/SU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 878.1800](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1800) → FXE — Speculum, Non-Illuminated

# FXE · Speculum, Non-Illuminated

_General, Plastic Surgery · 21 CFR 878.1800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXE

## Overview

- **Product Code:** FXE
- **Device Name:** Speculum, Non-Illuminated
- **Regulation:** [21 CFR 878.1800](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1800)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

## 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 (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXE](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXE)

**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