Disposable Sphincterotome
FDA 510(k) K242192 · Beijing Zksk Technology Co., Ltd.
510(k) numberK242192
Submission
- Device name
- Disposable Sphincterotome
- Applicant
- Beijing Zksk Technology Co., Ltd.
Beijing, CN - Received
- July 26, 2024
- Decision date
- February 6, 2025
- 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 |
More from Creo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231721 | Disposable Hot Biopsy ForcepsKGE · Traditional | 12/14/2023SE |
| K213217 | Disposable hemoclipPKL · Traditional | 11/14/2022SE |
| K213223 | Multi-Band LigatorFHN · Traditional | 06/06/2022SE |
| K213222 | Disposable Polypectomy SnareFDI · Traditional | 06/06/2022SE |
| K213239 | Endoscopic Injection NeedleFBK · Traditional | 06/02/2022SE |
Questions and answers
When was Disposable Sphincterotome cleared by the FDA?
Disposable Sphincterotome (K242192) received a 510(k) decision of Substantially Equivalent on February 6, 2025, 195 days after the submission was received.
What is the product code of K242192?
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.