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) → EPY — Speculum, Ent

# EPY · Speculum, Ent

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

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

## Overview

- **Product Code:** EPY
- **Device Name:** Speculum, Ent
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950086](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K950086.md) | PEDIA PALS, INCORPORATED | Pedia Pals, Inc. | Feb 7, 1995 | SESE |
| [K925754](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K925754.md) | ECONOM | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| [K853588](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K853588.md) | FIBRELIGHT NASAL SPECULA | Downs Surgical , Ltd. | Dec 18, 1985 | SESE |
| [K834189](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K834189.md) | JAKOBI SURG. INSTRUMENTS #7 44/47 | Imm Enterprises , Ltd. | Mar 6, 1984 | SESE |
| [K822373](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K822373.md) | EAR SURGERY SPECULUM | Treace Medical, Inc. | Sep 9, 1982 | SESE |
| [K822370](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K822370.md) | UNIVERSAL SPECULUM HOLDER | Treace Medical, Inc. | Sep 9, 1982 | SESE |
| [K822164](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K822164.md) | EAR SPECULI | Kelleher Corp. | Aug 11, 1982 | SESE |
| [K791123](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K791123.md) | EAR AND NOSE SPECULA | Xomed, Inc. | Jul 10, 1979 | SESE |
| [K780723](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K780723.md) | OTOSCOPE SPECULA | Abco Dealers, Inc. | May 9, 1978 | SESE |
| [K772385](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K772385.md) | THIN-BLADED NASAL SPECULUM | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| [K772380](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K772380.md) | FARRIOR OVAL SPECULUM | Edward Weck, Inc. | Jan 17, 1978 | SESE |
| [K772370](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/EPY/K772370.md) | BARRAQUER OVAL SPECULUM-VARIOUS SIZES | Edward Weck, Inc. | Jan 17, 1978 | SESE |

## Top Applicants

- Edward Weck, Inc. — 3 clearances
- Treace Medical, Inc. — 2 clearances
- Xomed, Inc. — 1 clearance
- Rudolf Riester GmbH & Co. KG — 1 clearance
- Pedia Pals, Inc. — 1 clearance

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

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