Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100) → HQQ — Apparatus, Cautery, Radiofrequency, Battery-Powered

# HQQ · Apparatus, Cautery, Radiofrequency, Battery-Powered

_Ophthalmic · 21 CFR 886.4100 · Class 2_

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

## Overview

- **Product Code:** HQQ
- **Device Name:** Apparatus, Cautery, Radiofrequency, Battery-Powered
- **Regulation:** [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910088](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQQ/K910088.md) | SCITECH BI-MANUAL ADAPTER CLIPS | Scitech Industries Partnership | Apr 8, 1991 | SESE |
| [K903878](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQQ/K903878.md) | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Mentor O & O, Inc. | Nov 5, 1990 | SESE |
| [K881001](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQQ/K881001.md) | MENTOR WET-FIELD*II COAGULATOR | Mentor O & O, Inc. | May 13, 1988 | SESE |

## Top Applicants

- Mentor O & O, Inc. — 2 clearances
- Scitech Industries Partnership — 1 clearance

---

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

**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
