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) → HQP — Unit, Cautery, Thermal, Battery-Powered # HQP · Unit, Cautery, Thermal, Battery-Powered _Ophthalmic · 21 CFR 886.4115 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP ## Overview - **Product Code:** HQP - **Device Name:** Unit, Cautery, Thermal, Battery-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 (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K121441](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K121441.md) | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Bovie Medical Corporation | Jul 20, 2012 | SESE | | [K083428](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K083428.md) | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Fiab Spa | Sep 1, 2009 | SESE | | [K062659](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K062659.md) | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Kirwan Surgical Products, Inc. | Mar 9, 2007 | SESE | | [K023506](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K023506.md) | SURGICAL MEDICAL DEVICE CAUTERY | Modern Medical Equipment Mfg., Ltd. | Jan 13, 2004 | SESE | | [K002547](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K002547.md) | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Starion Instruments | Oct 20, 2000 | SESE | | [K994019](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K994019.md) | CAUTERY GRASPER/DISSECTOR | Starion Instruments | Jan 20, 2000 | SESE | | [K990728](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K990728.md) | THERMAL CAUTERY DEVICE, FORCEPS | Starion Instruments | Jun 3, 1999 | SESE | | [K952784](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K952784.md) | OXBORO-MEDICAL CAUTERY TIP CLEANER | Oxboro Medical Intl., Inc. | Jul 13, 1995 | SESE | | [K945761](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K945761.md) | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | Aaron Medical Industries | Apr 10, 1995 | SESE | | [K945763](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K945763.md) | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP | Aaron Medical Industries | Feb 7, 1995 | SESE | | [K945762](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K945762.md) | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE | Aaron Medical Industries | Feb 7, 1995 | SESE | | [K945493](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K945493.md) | OPHTHALMIC CAUTERY | Aaron Medical Industries | Jan 30, 1995 | SESE | | [K933079](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K933079.md) | ELECTROCAUTERY SYSTEM MODEL 1980 | Pmt Corp. | Feb 22, 1994 | SESE | | [K875260](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K875260.md) | EFFNER CAUTERY INSTRUMENTS | Effner and Spreine Co. | Jun 6, 1988 | SESE | | [K841326](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K841326.md) | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE | | [K841325](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K841325.md) | REPLACE-A-TIP RECHARG. LOW TEMP. | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE | | [K840426](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K840426.md) | OPTHERM EXTRA FINE TIP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE | | [K840425](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K840425.md) | OPTHERM FINE TIP | Suncoast Medical Manufacturers, Inc. | May 9, 1984 | SESE | | [K820157](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K820157.md) | XOMED THERMAL MYRINGOTOMY SYSTEM | Xomed, Inc. | Mar 2, 1982 | SESE | | [K810016](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP/K810016.md) | REPLACABLE BATTERY PERFECTEMP CAUTERY | Medical Products Development, Inc. | Apr 23, 1981 | SESE | ## Top Applicants - Aaron Medical Industries — 4 clearances - Medical Products Development, Inc. — 4 clearances - Suncoast Medical Manufacturers, Inc. — 4 clearances - Starion Instruments — 3 clearances - Bovie Medical Corporation — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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