HQP · Unit, Cautery, Thermal, Battery-Powered
Ophthalmic · 21 CFR 886.4115 · Class 2
Overview
| Product Code | HQP |
|---|---|
| Device Name | Unit, Cautery, Thermal, Battery-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.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Bovie Medical Corporation | Jul 20, 2012 | SESE |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Fiab Spa | Sep 1, 2009 | SESE |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Kirwan Surgical Products, Inc. | Mar 9, 2007 | SESE |
| K023506 | SURGICAL MEDICAL DEVICE CAUTERY | Modern Medical Equipment Mfg., Ltd. | Jan 13, 2004 | SESE |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Starion Instruments | Oct 20, 2000 | SESE |
| K994019 | CAUTERY GRASPER/DISSECTOR | Starion Instruments | Jan 20, 2000 | SESE |
| K990728 | THERMAL CAUTERY DEVICE, FORCEPS | Starion Instruments | Jun 3, 1999 | SESE |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Oxboro Medical Intl., Inc. | Jul 13, 1995 | SESE |
| K945761 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | Aaron Medical Industries | Apr 10, 1995 | SESE |
| K945763 | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP | Aaron Medical Industries | Feb 7, 1995 | SESE |
| K945762 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE | Aaron Medical Industries | Feb 7, 1995 | SESE |
| K945493 | OPHTHALMIC CAUTERY | Aaron Medical Industries | Jan 30, 1995 | SESE |
| K933079 | ELECTROCAUTERY SYSTEM MODEL 1980 | Pmt Corp. | Feb 22, 1994 | SESE |
| K875260 | EFFNER CAUTERY INSTRUMENTS | Effner and Spreine Co. | Jun 6, 1988 | SESE |
| K841326 | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE |
| K841325 | REPLACE-A-TIP RECHARG. LOW TEMP. | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE |
| K840426 | OPTHERM EXTRA FINE TIP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE |
| K840425 | OPTHERM FINE TIP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE |
| K820157 | XOMED THERMAL MYRINGOTOMY SYSTEM | Xomed, Inc. | Mar 2, 1982 | SESE |
| K810016 | REPLACABLE BATTERY PERFECTEMP CAUTERY | Medical Products Development, Inc. | Apr 23, 1981 | SESE |
Top Applicants
- Suncoast Medical Manufacturers, Inc. — 4 clearances
- Medical Products Development, Inc. — 4 clearances
- Aaron Medical Industries — 4 clearances
- Starion Instruments — 3 clearances
- Xomed, Inc. — 1 clearance
