Plasmakinetic Endourology System
FDA 510(k) K003569 · Gyrus Medical , Ltd.
510(k) numberK003569
Submission
- Device name
- Plasmakinetic Endourology System
- Applicant
- Gyrus Medical , Ltd.
Cardiff, Wales, GB - Received
- November 20, 2000
- Decision date
- December 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K260962 | SphincterotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 05/21/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
More from Creo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K050550 | Gyrus General Purpose Electrosurgical GeneratorGEI · Traditional | 11/09/2005SE |
| K050460 | Gyrus Plasmacision and Plasmablend ElectrodesGEI · Traditional | 10/25/2005SE |
| K041999 | Gyrus Plasma Skin Resurfacing SystemGEI · Traditional | 03/02/2005SE |
| K041633 | Gyrus Plasmacision Laparoscopic SpatulaGEI · Traditional | 10/22/2004SE |
| K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…GEI · Traditional | 09/10/2004SE |
| K024286 | Gyrus Open ForcepsGEI · Traditional | 11/17/2003SE |
| K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories)GEI · Traditional | 07/21/2003SE |
| K031082 | Everest Bipolar L Hook & PK Bipolar L HookGEI · Special | 05/21/2003SE |
| K031081 | Everest LP Bipolar Scissors and Gyrus LP Bipolar ScissorsGEI · Special | 05/21/2003SE |
| K031079 | Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGEI · Special | 05/21/2003SE |
Questions and answers
When was Plasmakinetic Endourology System cleared by the FDA?
Plasmakinetic Endourology System (K003569) received a 510(k) decision of Substantially Equivalent on December 19, 2000, 29 days after the submission was received.
What is the product code of K003569?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.