HQO · Unit, Cautery, Thermal, Ac-Powered
Ophthalmic · 21 CFR 886.4115 · Class 2
Overview
| Product Code | HQO |
|---|---|
| Device Name | Unit, Cautery, Thermal, Ac-Powered |
| Regulation | 21 CFR 886.4115 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | Starion Instruments | Apr 13, 2007 | SESE |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | Starion Instruments | Dec 9, 2004 | SESE |
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Geiger Medical Technologies, Inc. | Oct 23, 2000 | SESE |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Starion Instruments | Jun 14, 2000 | SESE |
| K971538 | MENTOR GEMINI HEMOSTATIC ERASER | Mentor Ophthalmics, Inc. | Jul 14, 1997 | SESE |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Dutch Ophthalmic USA, Inc. | Aug 29, 1996 | SESE |
| K943031 | BIPOLAR ELECTROSURGICAL PENCIL | Boston Surgical Products, Inc. | Sep 23, 1994 | SESE |
| K900913 | ADLER DISPOSABLE BIPOLAR CORD | Adler Instrument Co. | Apr 4, 1990 | SESE |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Spembly Medical , Ltd. | Jan 4, 1988 | SESE |
| K852075 | SITE-MALIS BIPOLAR COAGULATOR MODULE | Valley Forge Scientific Corp. | Aug 20, 1985 | SESE |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Mecron Medical Products, Inc. | Aug 12, 1985 | SESE |
| K810017 | MICROSURG CAUTERY | Medical Products Development, Inc. | Jan 5, 1981 | SESP |
Top Applicants
- Starion Instruments — 3 clearances
- Valley Forge Scientific Corp. — 1 clearance
- Spembly Medical , Ltd. — 1 clearance
- Mentor Ophthalmics, Inc. — 1 clearance
- Medical Products Development, Inc. — 1 clearance
