Papillotome
FDA 510(k) K962346 · United States Endoscopy Group, Inc.
510(k) numberK962346
Submission
- Device name
- Papillotome
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- June 18, 1996
- Decision date
- August 8, 1996
- 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 |
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| K200745 | Lariat, Hot/Cold SnareFDI · Special | 04/21/2020SE |
| K192059 | Bio Guard Air/Water & Suction ValvesODC · Special | 09/17/2019SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | 08/01/2019SE |
| K182909 | Roth Net Retriever Product LineFDI · Special | 11/21/2018SE |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | 09/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | 01/05/2018SE |
| K172805 | gi-4000 Electrosurgical GeneratorGEI · Special | 10/23/2017SE |
| K163495 | AdvanCE capsule endoscope delivery deviceNEZ · Traditional | 03/10/2017SE |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon…FDF · Special | 01/06/2017SE |
Questions and answers
When was Papillotome cleared by the FDA?
Papillotome (K962346) received a 510(k) decision of Substantially Equivalent on August 8, 1996, 51 days after the submission was received.
What is the product code of K962346?
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.