Ac Powered Thermal Cautery Unit
FDA 510(k) K000893 · Starion Instruments
510(k) numberK000893
Submission
- Device name
- Ac Powered Thermal Cautery Unit
- Applicant
- Starion Instruments
Saratoga, CA, US - Received
- March 20, 2000
- Decision date
- June 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQO – Unit, Cautery, Thermal, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4115
- Specialty
- Ophthalmic
Other 510(k)s with product code HQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K844775 | Effner-Eye Cautery with Battery HandleHQO · Traditional | Mecron Medical Products, Inc. | 08/12/1985SE |
More from Mecron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070871 | Starion Universal Power SupplyHQO · Special | 04/13/2007SE |
| K062257 | Starion Instruments Thermal Litigating ShearsGEI · Special | 10/10/2006SE |
| K050308 | Thermal Cautery ProbeHQR · Special | 02/25/2005SE |
| K043155 | Starion Universal Power Supply (Ups)HQO · Special | 12/09/2004SE |
| K002547 | Starion Instruments Power Point Cautery Grasper/DissectorHQP · Traditional | 10/20/2000SE |
| K001273 | Starion Instruments Power Point Cautery ClampGEI · Traditional | 06/14/2000SE |
| K001262 | Thermal Cautery ForcepsGEI · Traditional | 06/14/2000SE |
| K000296 | Starion Cautery HookGEI · Traditional | 03/07/2000SE |
| K000250 | Cautery Forceps with FootswitchGEI · Traditional | 03/07/2000SE |
| K994019 | Cautery Grasper/DissectorHQP · Traditional | 01/20/2000SE |
Questions and answers
When was Ac Powered Thermal Cautery Unit cleared by the FDA?
Ac Powered Thermal Cautery Unit (K000893) received a 510(k) decision of Substantially Equivalent on June 14, 2000, 86 days after the submission was received.
What is the product code of K000893?
The FDA product code is HQO – Unit, Cautery, Thermal, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.