510(k) K043155
- Device
- STARION UNIVERSAL POWER SUPPLY (UPS)
- Applicant
- STARION INSTRUMENTS
- 510(k) number
- K043155
- Product code
- HQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-09
- Date received
- 2004-11-15
- Regulation
- 886.4115
- Classification name
- Unit, Cautery, Thermal, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN GRIGSBY
- Address
- 20665 4th St. Saratoga CA US 95070 95070
FDA Registration Numbers#
- 1223422
- 1930126
Source Documents#
Other 510(k) Records For Product Code HQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | Starion Instruments | 2007-04-13 |
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Geiger Medical Technologies, Inc. | 2000-10-23 |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Starion Instruments | 2000-06-14 |
| K971538 | MENTOR GEMINI HEMOSTATIC ERASER | Mentor Ophthalmics, Inc. | 1997-07-14 |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1996-08-29 |
| K943031 | BIPOLAR ELECTROSURGICAL PENCIL | Boston Surgical Products, Inc. | 1994-09-23 |
| K900913 | ADLER DISPOSABLE BIPOLAR CORD | Adler Instrument Co. | 1990-04-04 |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Spembly Medical , Ltd. | 1988-01-04 |
| K852075 | SITE-MALIS BIPOLAR COAGULATOR MODULE | Valley Forge Scientific Corp. | 1985-08-20 |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Mecron Medical Products, Inc. | 1985-08-12 |
| K810017 | MICROSURG CAUTERY | Medical Products Development, Inc. | 1981-01-05 |
Legacy Summary#
summary
FDA Review#
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