Zimmon Needle Knife Papillotome
FDA 510(k) K171993 · Wilson-Cook Medical Inc./Cook Endoscopy
510(k) numberK171993
Submission
- Device name
- Zimmon Needle Knife Papillotome
- Applicant
- Wilson-Cook Medical Inc./Cook Endoscopy
Winston-Salem, NC, US - Received
- July 3, 2017
- Decision date
- August 17, 2017
- 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 |
|---|---|---|
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)FBK · Traditional | 12/19/2019SE |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…KNS · Traditional | 05/24/2018SE |
| K172288 | Fusion OMNI SphincterotomeKNS · Traditional | 04/17/2018SE |
| K171607 | Bronchi and Gastrointestinal Cytology BrushFDX · Traditional | 07/31/2017SE |
| K121505 | Disposable Hemostasis ChipPKL · Traditional | 08/31/2012SE |
| K111895 | Echotip(R) Ultra Fiducial NeedleNEU · Traditional | 04/27/2012SE |
Questions and answers
When was Zimmon Needle Knife Papillotome cleared by the FDA?
Zimmon Needle Knife Papillotome (K171993) received a 510(k) decision of Substantially Equivalent on August 17, 2017, 45 days after the submission was received.
What is the product code of K171993?
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.