Horizons Papillotome
FDA 510(k) K002236 · Horizons Intl. Corp.
510(k) numberK002236
Submission
- Device name
- Horizons Papillotome
- Applicant
- Horizons Intl. Corp.
Aguadilla, PR, US - Received
- July 24, 2000
- Decision date
- January 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K083049 | Tornado Rotatabel Snare and Polyp CatcherFDI · Traditional | 12/23/2008SE |
| K022268 | Horizons Reusable Polypectomy SnaresFDI · Traditional | 10/25/2002SE |
| K022243 | Horizons Reusable Hot Biopsy ForcepsKGE · Traditional | 10/25/2002SE |
| K022546 | Horizons Anso Transbronchial Aspiration NeedlesEOQ · Traditional | 08/12/2002SE |
| K021998 | Horizons Cytology BrushFDX · Traditional | 07/12/2002SE |
| K021706 | Horizons Hot Biopsy ForcepsKGE · Traditional | 06/21/2002SE |
| K011667 | Horizons International Polypectomy SnaresFDI · Traditional | 08/16/2001SE |
| K010448 | Horizons International Varices Injection NeedlesFBK · Traditional | 05/16/2001SE |
| K002235 | Horizons Ercp CannulaFGE · Traditional | 01/23/2001SE |
Questions and answers
When was Horizons Papillotome cleared by the FDA?
Horizons Papillotome (K002236) received a 510(k) decision of Substantially Equivalent on January 23, 2001, 183 days after the submission was received.
What is the product code of K002236?
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.