510(k) K232476
K232476 is an FDA 510(k) premarket notification submitted by Zhejiang Soudon Medical Technology Co., Ltd. for the device "Disposable Sphincterotome". The FDA issued a decision of Substantially Equivalent on November 7, 2023. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Zhejiang Soudon Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2023
- Date Received
- August 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type