Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4115](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4115) → HQO — Unit, Cautery, Thermal, Ac-Powered

# HQO · Unit, Cautery, Thermal, Ac-Powered

_Ophthalmic · 21 CFR 886.4115 · Class 2_

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

## Overview

- **Product Code:** HQO
- **Device Name:** Unit, Cautery, Thermal, Ac-Powered
- **Regulation:** [21 CFR 886.4115](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4115)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

## Classification Rationale

Class II.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070871](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K070871.md) | STARION  UNIVERSAL POWER SUPPLY | Starion Instruments | Apr 13, 2007 | SESE |
| [K043155](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K043155.md) | STARION UNIVERSAL POWER SUPPLY (UPS) | Starion Instruments | Dec 9, 2004 | SESE |
| [K002341](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K002341.md) | THERMAL CAUTERY UNIT, MODEL 150 | Geiger Medical Technologies, Inc. | Oct 23, 2000 | SESE |
| [K000893](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K000893.md) | AC POWERED THERMAL CAUTERY UNIT | Starion Instruments | Jun 14, 2000 | SESE |
| [K971538](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K971538.md) | MENTOR GEMINI HEMOSTATIC ERASER | Mentor Ophthalmics, Inc. | Jul 14, 1997 | SESE |
| [K962135](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K962135.md) | D.O.R.C. MICRODIATHERMY SYSTEM | Dutch Ophthalmic USA, Inc. | Aug 29, 1996 | SESE |
| [K943031](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K943031.md) | BIPOLAR ELECTROSURGICAL PENCIL | Boston Surgical Products, Inc. | Sep 23, 1994 | SESE |
| [K900913](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K900913.md) | ADLER DISPOSABLE BIPOLAR CORD | Adler Instrument Co. | Apr 4, 1990 | SESE |
| [K874367](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K874367.md) | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Spembly Medical , Ltd. | Jan 4, 1988 | SESE |
| [K852075](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K852075.md) | SITE-MALIS BIPOLAR COAGULATOR MODULE | Valley Forge Scientific Corp. | Aug 20, 1985 | SESE |
| [K844775](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K844775.md) | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Mecron Medical Products, Inc. | Aug 12, 1985 | SESE |
| [K810017](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQO/K810017.md) | MICROSURG CAUTERY | Medical Products Development, Inc. | Jan 5, 1981 | SESP |

## Top Applicants

- Starion Instruments — 3 clearances
- Adler Instrument Co. — 1 clearance
- Boston Surgical Products, Inc. — 1 clearance
- Dutch Ophthalmic USA, Inc. — 1 clearance
- Geiger Medical Technologies, Inc. — 1 clearance

---

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

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