Precision Tuna Office System with No Rectal Temperature Monitoring Tape
FDA 510(k) K011787 · Vidamed, Inc.
510(k) numberK011787
Submission
- Device name
- Precision Tuna Office System with No Rectal Temperature Monitoring Tape
- Applicant
- Vidamed, Inc.
Fremont, CA, US - Received
- June 8, 2001
- Decision date
- July 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| K002583 | Tuna (Trans Urethra Needle) Office SystemKNS · Traditional | 02/13/2001SE |
| 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 Precision Tuna Office System with No Rectal Temperature Monitoring Tape cleared by the FDA?
Precision Tuna Office System with No Rectal Temperature Monitoring Tape (K011787) received a 510(k) decision of Substantially Equivalent on July 6, 2001, 28 days after the submission was received.
What is the product code of K011787?
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.