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) → KAG — Holder, Speculum, Ent

# KAG · Holder, 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/KAG

## Overview

- **Product Code:** KAG
- **Device Name:** Holder, 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K842931](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/KAG/K842931.md) | DRABKIN REAGENT | E K Ind., Inc. | Sep 21, 1984 | SESE |
| [K822857](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/KAG/K822857.md) | CPI PRINTER | Cardiac Pacemakers, Inc. | Jan 8, 1983 | SESE |

## Top Applicants

- Cardiac Pacemakers, Inc. — 1 clearance
- E K Ind., Inc. — 1 clearance

---

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

**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