Papillotome Product
FDA 510(k) K802444 · Mill-Rose Laboratory
510(k) numberK802444
Submission
- Device name
- Papillotome Product
- Applicant
- Mill-Rose Laboratory
Mchenry, IL, US - Received
- October 7, 1980
- Decision date
- October 23, 1980
- 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 |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
Questions and answers
When was Papillotome Product cleared by the FDA?
Papillotome Product (K802444) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 16 days after the submission was received.
What is the product code of K802444?
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.