Apparatus, Cautery, Radiofrequency, Ac-Powered
An AC-Powered Radiofrequency Cautery Apparatus is a mains-powered ophthalmic surgical device that delivers radiofrequency electrical energy to tissues for controlled cauterization and hemostasis during ophthalmic and periocular surgical procedures, offering consistent and sustained power delivery compared to battery-powered units. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQR and is regulated under 21 CFR 886.4100, within the Ophthalmic medical specialty. It is eligible for third-party review.
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Basic Information
- Product Code
- HQR
- Device Class
- FDA class 2
- Regulation Number
- 886.4100
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050308 | THERMAL CAUTERY PROBE | Feb 25, 2005 | Substantially Equivalent | Starion Instruments |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Apr 04, 1999 | Substantially Equivalent | Ophthalmic Technologies, Inc. |
| K980522 | REFRACTEC MCS-100 | Jul 22, 1998 | Unknown | Refractec, Inc. |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | Mar 13, 1998 | Substantially Equivalent | C.M. Chance , Ltd. |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Mar 04, 1996 | Substantially Equivalent | Storz |
| K955158 | SURGITRON | Feb 09, 1996 | Substantially Equivalent | Ellman Intl., Inc. |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Jan 05, 1996 | Substantially Equivalent | Gamp & Assoc. |
| K941495 | RETURN PATH DIATHERMY HANDLE | Jul 15, 1994 | Substantially Equivalent | Mira, Inc. |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Feb 16, 1994 | Substantially Equivalent | Mentor O & O, Inc. |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Jan 22, 1990 | Substantially Equivalent | Advanced Surgical Products, Inc. |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | Feb 20, 1987 | Substantially Equivalent | United Surgical Corp. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.