HQO — Unit, Cautery, Thermal, Ac-Powered Class II
FDA product code HQO covers "Unit, Cautery, Thermal, Ac-Powered", a Class II medical device regulated under 21 CFR 886.4115. Submissions are reviewed by the Ophthalmic panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQO
- Device Class
- Class II
- Regulation Number
- 886.4115
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070871 | starion instruments | STARION UNIVERSAL POWER SUPPLY | April 13, 2007 |
| K043155 | starion instruments | STARION UNIVERSAL POWER SUPPLY (UPS) | December 9, 2004 |
| K002341 | geiger medical technologies | THERMAL CAUTERY UNIT, MODEL 150 | October 23, 2000 |
| K000893 | starion instruments | AC POWERED THERMAL CAUTERY UNIT | June 14, 2000 |
| K971538 | mentor ophthalmics | MENTOR GEMINI HEMOSTATIC ERASER | July 14, 1997 |
| K962135 | dutch ophthalmic usa | D.O.R.C. MICRODIATHERMY SYSTEM | August 29, 1996 |
| K943031 | boston surgical products | BIPOLAR ELECTROSURGICAL PENCIL | September 23, 1994 |
| K900913 | adler instrument | ADLER DISPOSABLE BIPOLAR CORD | April 4, 1990 |
| K874367 | spembly medical | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | January 4, 1988 |
| K852075 | valley forge scientific | SITE-MALIS BIPOLAR COAGULATOR MODULE | August 20, 1985 |
| K844775 | mecron medical products | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | August 12, 1985 |
| K810017 | medical products development | MICROSURG CAUTERY | January 5, 1981 |