Tuna (Trans Urethra Needle) Office System
FDA 510(k) K002583 · Vidamed, Inc.
510(k) numberK002583
Submission
- Device name
- Tuna (Trans Urethra Needle) Office System
- Applicant
- Vidamed, Inc.
Fremont, CA, US - Received
- August 18, 2000
- Decision date
- February 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K014224 | Precision Plus Tuna Office SystemGEI · Special | 01/23/2002SE |
| K012587 | RF Generators, Disposable Cartridge Kit, Disposable Cartridge, Reusable Handle…KNS · Traditional | 12/11/2001SE |
| K011787 | Precision Tuna Office System with No Rectal Temperature Monitoring TapeKNS · Special | 07/06/2001SE |
| K973366 | Cobra Hand PieceKNS · Traditional | 11/26/1997SE |
| K965199 | Tuna 5 CatheterGEI · Traditional | 04/30/1997SE |
| K965061 | Vidamed Modedl 7600 RF GeneratorGEI · Traditional | 01/28/1997SE |
| K963180 | Vidamed RF Generator Data RecorderGEI · Traditional | 10/10/1996SE |
| K960918 | Vidamed Tuna (Transurethral Needle Ablation) SystemGEI · Traditional | 10/08/1996SE |
| K955035 | Vidamed Series 7205 Electrosurgical GeneratorGEI · Traditional | 11/29/1995SE |
| K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge)…GEI · Traditional | 06/09/1995SE |
Questions and answers
When was Tuna (Trans Urethra Needle) Office System cleared by the FDA?
Tuna (Trans Urethra Needle) Office System (K002583) received a 510(k) decision of Substantially Equivalent on February 13, 2001, 179 days after the submission was received.
What is the product code of K002583?
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.