Clearance Summary
SB Knife Jr2 (MD-47702 and MD-47702L) received FDA 510(k) clearance under submission number K241855, sponsored by Sb-Kawasumi Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-03-26.
- Submission: K241855
- Applicant / Sponsor: Sb-Kawasumi Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2025-03-26
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.