5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip TAPER-30MM Cutting Wire, 5.0 French
FDA 510(k) K992402 · Telemed Systems, Inc.
510(k) numberK992402
Submission
- Device name
- 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip TAPER-30MM Cutting Wire, 5.0 French
- Applicant
- Telemed Systems, Inc.
Marlborough, MA, US - Received
- July 19, 1999
- Decision date
- December 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
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| 510(k) | Device | Decision |
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| K020379 | PPD Balloon Dilatation CatheterKNT · Special | 05/06/2002SE |
| K013737 | Modification to: 3-LUMEN Duralon Occlusion BalloonFGE · Special | 03/01/2002SE |
| K010412 | Flexible Endoscopic ScissorsOCZ · Traditional | 04/02/2001SE |
| K992390 | Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval…KGE · Traditional | 12/22/1999SE |
| K974312 | Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable…KNW · Traditional | 01/21/1998SE |
| K974300 | Telemed Systems Retrieval BasketOCZ · Traditional | 12/19/1997SE |
| K901435 | Gastrointestinal Cytology BrushFDX · Traditional | 07/16/1990SE |
| K901427 | Biliary Stone Retrieval and Occlusion BalloonFGE · Traditional | 06/22/1990SE |
| K901433 | Sure-Flex Anastomotic Balloon DilatorFGE · Traditional | 06/21/1990SE |
| K901432 | Biliary Balloon DilatorFGE · Traditional | 06/21/1990SE |
Questions and answers
When was 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip TAPER-30MM Cutting Wire, 5.0 French cleared by the FDA?
5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip TAPER-30MM Cutting Wire, 5.0 French (K992402) received a 510(k) decision of Substantially Equivalent on December 22, 1999, 156 days after the submission was received.
What is the product code of K992402?
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.