Wiltek Papillotome
FDA 510(k) K894861 · Wiltek Medical, Inc.
510(k) numberK894861
Submission
- Device name
- Wiltek Papillotome
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- July 31, 1989
- Decision date
- December 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | 04/13/1999SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | 02/15/1994SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K914131 | Wiltek Electrocautery AdaptorGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
Questions and answers
When was Wiltek Papillotome cleared by the FDA?
Wiltek Papillotome (K894861) received a 510(k) decision of Substantially Equivalent on December 21, 1989, 143 days after the submission was received.
What is the product code of K894861?
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.