SITE-MALIS BIPOLAR COAGULATOR MODULE
FDA 510(k) clearance K852075 · decided 1985-08-20
Clearance details
- K-number
- K852075
- Device name
- SITE-MALIS BIPOLAR COAGULATOR MODULE
- Applicant
- Valley Forge Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-13
- Decision date
- 1985-08-20
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- HQO
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Valley Forge, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STARION UNIVERSAL POWER SUPPLY (K070871) | Starion Instruments | 2007-04-13 |
| STARION UNIVERSAL POWER SUPPLY (UPS) (K043155) | Starion Instruments | 2004-12-09 |
| THERMAL CAUTERY UNIT, MODEL 150 (K002341) | Geiger Medical Technologies, Inc. | 2000-10-23 |
| AC POWERED THERMAL CAUTERY UNIT (K000893) | Starion Instruments | 2000-06-14 |
| MENTOR GEMINI HEMOSTATIC ERASER (K971538) | Mentor Ophthalmics, Inc. | 1997-07-14 |
| D.O.R.C. MICRODIATHERMY SYSTEM (K962135) | Dutch Ophthalmic USA, Inc. | 1996-08-29 |
| BIPOLAR ELECTROSURGICAL PENCIL (K943031) | Boston Surgical Products, Inc. | 1994-09-23 |
| ADLER DISPOSABLE BIPOLAR CORD (K900913) | Adler Instrument Co. | 1990-04-04 |
| VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (K874367) | Spembly Medical , Ltd. | 1988-01-04 |
| EFFNER-EYE CAUTERY WITH BATTERY HANDLE (K844775) | Mecron Medical Products, Inc. | 1985-08-12 |
| MICROSURG CAUTERY (K810017) | Medical Products Development, Inc. | 1981-01-05 |
Recalls involving this device
No recalls on record reference this clearance.