Unit, Cautery, Thermal, Battery-Powered
A Battery-Powered Thermal Cautery Unit is a portable ophthalmic surgical device that uses battery-powered resistive heating to apply localized thermal energy to ocular and periocular tissues for hemostasis or minor tissue ablation, providing a portable alternative to AC-powered cautery devices. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQP and is regulated under 21 CFR 886.4115, within the Ophthalmic medical specialty. It is eligible for third-party review.
Basic Information
- Product Code
- HQP
- Device Class
- FDA class 2
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Jul 20, 2012 | Substantially Equivalent | BOVIE MEDICAL CORPORATION |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Sep 01, 2009 | Substantially Equivalent | FIAB SPA |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Mar 09, 2007 | Substantially Equivalent | KIRWAN SURGICAL PRODUCTS, INC. |
| K023506 | SURGICAL MEDICAL DEVICE CAUTERY | Jan 13, 2004 | Substantially Equivalent | MODERN MEDICAL EQUIPMENT MFG., LTD. |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Oct 20, 2000 | Substantially Equivalent | STARION INSTRUMENTS |
| K994019 | CAUTERY GRASPER/DISSECTOR | Jan 20, 2000 | Substantially Equivalent | STARION INSTRUMENTS |
| K990728 | THERMAL CAUTERY DEVICE, FORCEPS | Jun 03, 1999 | Substantially Equivalent | STARION INSTRUMENTS |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Jul 13, 1995 | Substantially Equivalent | OXBORO MEDICAL INTL., INC. |
| K945761 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | Apr 10, 1995 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K945763 | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP | Feb 07, 1995 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K945762 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE | Feb 07, 1995 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K945493 | OPHTHALMIC CAUTERY | Jan 30, 1995 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K933079 | ELECTROCAUTERY SYSTEM MODEL 1980 | Feb 22, 1994 | Substantially Equivalent | PMT CORP. |
| K875260 | EFFNER CAUTERY INSTRUMENTS | Jun 06, 1988 | Substantially Equivalent | EFFNER AND SPREINE CO. |
| K841326 | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | May 09, 1984 | Substantially Equivalent | SUNCOAST MEDICAL MANUFACTURERS, INC. |
| K841325 | REPLACE-A-TIP RECHARG. LOW TEMP. | May 09, 1984 | Substantially Equivalent | SUNCOAST MEDICAL MANUFACTURERS, INC. |
| K840426 | OPTHERM EXTRA FINE TIP | May 09, 1984 | Substantially Equivalent | SUNCOAST MEDICAL MANUFACTURERS, INC. |
| K840425 | OPTHERM FINE TIP | May 09, 1984 | Substantially Equivalent | SUNCOAST MEDICAL MANUFACTURERS, INC. |
| K820157 | XOMED THERMAL MYRINGOTOMY SYSTEM | Mar 02, 1982 | Substantially Equivalent | XOMED, INC. |
| K810016 | REPLACABLE BATTERY PERFECTEMP CAUTERY | Apr 23, 1981 | Substantially Equivalent | MEDICAL PRODUCTS DEVELOPMENT, INC. |
| K810013 | MULTIPERFECTEMP CAUTERY | Apr 23, 1981 | Substantially Equivalent | MEDICAL PRODUCTS DEVELOPMENT, INC. |
| K810012 | MULTIMICRO SURGICAL CAUTERY | Apr 23, 1981 | Substantially Equivalent | MEDICAL PRODUCTS DEVELOPMENT, INC. |
| K801078 | PERFECTEMP OPHTHALMIC CAUTERY | Jun 04, 1980 | Substantially Equivalent | MEDICAL PRODUCTS DEVELOPMENT, INC. |
| K771189 | HOT TEMP CAUTERY | Jul 11, 1977 | Substantially Equivalent | EDWARD WECK, INC. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.