Effner-Eye Cautery with Battery Handle
FDA 510(k) K844775 · Mecron Medical Products, Inc.
510(k) numberK844775
Submission
- Device name
- Effner-Eye Cautery with Battery Handle
- Applicant
- Mecron Medical Products, Inc.
Port Washington, NY, US - Received
- December 10, 1984
- Decision date
- August 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQO – Unit, Cautery, Thermal, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4115
- Specialty
- Ophthalmic
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|---|---|---|---|
| K070871 | Starion Universal Power SupplyHQO · Special | Starion Instruments | 04/13/2007SE |
| K043155 | Starion Universal Power Supply (Ups)HQO · Special | Starion Instruments | 12/09/2004SE |
| K002341 | Thermal Cautery Unit, Model 150HQO · Traditional | Geiger Medical Technologies, Inc. | 10/23/2000SE |
| K000893 | Ac Powered Thermal Cautery UnitHQO · Traditional | Starion Instruments | 06/14/2000SE |
| K971538 | Mentor Gemini Hemostatic EraserHQO · Traditional | Mentor Ophthalmics, Inc. | 07/14/1997SE |
| K962135 | D.O.R.C. Microdiathermy SystemHQO · Traditional | Dutch Ophthalmic USA, Inc. | 08/29/1996SE |
| K943031 | Bipolar Electrosurgical PencilHQO · Traditional | Boston Surgical Products, Inc. | 09/23/1994SE |
| K900913 | Adler Disposable Bipolar CordHQO · Traditional | Adler Instrument Co. | 04/04/1990SE |
| K874367 | Various Cardiac Cryoprobes Having Dia. & Cos. DiffHQO · Traditional | Spembly Medical , Ltd. | 01/04/1988SE |
| K852075 | Site-Malis Bipolar Coagulator ModuleHQO · Traditional | Valley Forge Scientific Corp. | 08/20/1985SE |
More from Valley Forge Scientific Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861138 | Mash DermatomeGFD · Traditional | 04/14/1986SE |
| K854191 | Mecron Uncemented Structured Stem Hip · Traditional | 11/13/1985SE |
| K844774 | Effner Fiber Optic Cables for Cold Light TransmissFCR · Traditional | 04/22/1985SE |
| K844488 | Mecron Cemented Structured Stem Hip ProsthesisKWL · Traditional | 03/12/1985SE |
| K844487 | Mecron Femoral Head W/Cone AS Unipolar or BipolarKWL · Traditional | 02/19/1985SE |
| K844486 | Mecron Mrc-Headless Femoral ComponentKWL · Traditional | 02/19/1985SE |
| K844773 | Eff-Effner BulbsFFS · Traditional | 01/08/1985SE |
| K843449 | Autodynamic Compression Hip Screw-PlateKTT · Traditional | 10/22/1984SE |
| K843554 | Bone ScrewsKTW · Traditional | 10/01/1984SE |
| K843553 | Bone PlatesKTW · Traditional | 10/01/1984SE |
Questions and answers
When was Effner-Eye Cautery with Battery Handle cleared by the FDA?
Effner-Eye Cautery with Battery Handle (K844775) received a 510(k) decision of Substantially Equivalent on August 12, 1985, 245 days after the submission was received.
What is the product code of K844775?
The FDA product code is HQO – Unit, Cautery, Thermal, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.