Papillotomes
FDA 510(k) K820240 · American Endoscopy, Inc.
510(k) numberK820240
Submission
- Device name
- Papillotomes
- Applicant
- American Endoscopy, Inc.
Mchenry, IL, US - Received
- January 29, 1982
- Decision date
- March 26, 1982
- 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 |
|---|---|---|
| K853274 | American Dilatation SystemKNQ · Traditional | 10/17/1985SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | 07/19/1984SE |
| K833491 | Endo Bite BlockKTI · Traditional | 04/25/1984SE |
| K840818 | Biopsy ForcepsFCL · Traditional | 04/13/1984SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | 01/03/1984SE |
| K833492 | Percutaneous Endoscopic GastroscopyKNT · Traditional | 11/29/1983SE |
| K832458 | Automatic EndoscopeNVE · Traditional | 10/20/1983SE |
| K821818 | Retrieval BalloonsKOD · Traditional | 09/24/1982SE |
| K821819 | Pigtail StentsFGE · Traditional | 08/20/1982SE |
| K822062 | Ball Tip Coagulating ElectrodesGEI · Traditional | 08/19/1982SE |
Questions and answers
When was Papillotomes cleared by the FDA?
Papillotomes (K820240) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 56 days after the submission was received.
What is the product code of K820240?
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.