Various Cardiac Cryoprobes Having Dia. & Cos. Diff
FDA 510(k) K874367 · Spembly Medical , Ltd.
510(k) numberK874367
Submission
- Device name
- Various Cardiac Cryoprobes Having Dia. & Cos. Diff
- Applicant
- Spembly Medical , Ltd.
England, GB - Received
- October 23, 1987
- Decision date
- January 4, 1988
- 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 |
| 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 |
|---|---|---|
| K925129 | SelectorGCJ · Traditional | 04/23/1993SE |
| K903303 | Spembly Medical 242 Cryounit/Series 242 CryoprobesHPS · Traditional | 10/11/1990SE |
| K901974 | Selector Ultrasonic Surgical AspiratorLFL · Traditional | 09/05/1990SE |
| K882568 | 130 Cryo Unit & Assoc. Cryoprobes & SprayGEH · Traditional | 09/27/1988SE |
| K882963 | Spembly Medical 142 Cryo UnitGEH · Traditional | 08/08/1988SE |
| K882962 | Series 40 & Series 42 Cryoprobes (R Series)GEH · Traditional | 08/08/1988SE |
| K840497 | Obstetric Pulsar Two Channel TENSGZJ · Traditional | 04/16/1984SE |
| K832385 | Cryoprobes MC-1400-CRYOSURG-CONSOLEGEH · Traditional | 09/12/1983SE |
| K832334 | Cryomedics 5000 Cryosurgical ConsoleGEH · Traditional | 08/12/1983SE |
| K832140 | Cryomedics 5000 CryoprobesGEH · Traditional | 08/12/1983SE |
Questions and answers
When was Various Cardiac Cryoprobes Having Dia. & Cos. Diff cleared by the FDA?
Various Cardiac Cryoprobes Having Dia. & Cos. Diff (K874367) received a 510(k) decision of Substantially Equivalent on January 4, 1988, 73 days after the submission was received.
What is the product code of K874367?
The FDA product code is HQO – Unit, Cautery, Thermal, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.