HQR · Apparatus, Cautery, Radiofrequency, Ac-Powered
Ophthalmic · 21 CFR 886.4100 · Class 2
Overview
| Product Code | HQR |
|---|---|
| Device Name | Apparatus, Cautery, Radiofrequency, Ac-Powered |
| Regulation | 21 CFR 886.4100 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
Classification Rationale
Class II.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050308 | THERMAL CAUTERY PROBE | Starion Instruments | Feb 25, 2005 | SESE |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | Apr 4, 1999 | SESE |
| K980522 | REFRACTEC MCS-100 | Refractec, Inc. | Jul 22, 1998 | SESU |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | Mar 13, 1998 | SESE |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Storz | Mar 4, 1996 | SESE |
| K955158 | SURGITRON | Ellman Intl., Inc. | Feb 9, 1996 | SESE |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | Jan 5, 1996 | SESE |
| K941495 | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | Jul 15, 1994 | SESE |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Mentor O & O, Inc. | Feb 16, 1994 | SESE |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Advanced Surgical Products, Inc. | Jan 22, 1990 | SESE |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | United Surgical Corp. | Feb 20, 1987 | SESE |
Top Applicants
- United Surgical Corp. — 1 clearance
- Storz — 1 clearance
- Starion Instruments — 1 clearance
- Refractec, Inc. — 1 clearance
- Ophthalmic Technologies, Inc. — 1 clearance
