HQR — Apparatus, Cautery, Radiofrequency, Ac-Powered Class II
FDA product code HQR covers "Apparatus, Cautery, Radiofrequency, Ac-Powered", a Class II medical device regulated under 21 CFR 886.4100. Submissions are reviewed by the Ophthalmic panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQR
- Device Class
- Class II
- Regulation Number
- 886.4100
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050308 | starion instruments | THERMAL CAUTERY PROBE | February 25, 2005 |
| K990064 | ophthalmic technologies | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | April 4, 1999 |
| K980522 | refractec | REFRACTEC MCS-100 | July 22, 1998 |
| K972749 | c.m. chance | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | March 13, 1998 |
| K952151 | storz | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR C | March 4, 1996 |
| K955158 | ellman intl | SURGITRON | February 9, 1996 |
| K952569 | gamp and assoc | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | January 5, 1996 |
| K941495 | mira | RETURN PATH DIATHERMY HANDLE | July 15, 1994 |
| K934320 | mentor o and o | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A | February 16, 1994 |
| K895800 | advanced surgical products | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | January 22, 1990 |
| K870194 | united surgical | UNITED SURGICAL CORP. DIATHERMIC PLUS | February 20, 1987 |