Clearance Summary
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long received FDA 510(k) clearance under submission number K152771, sponsored by Sumitomo Bakelite Co., Ltd.. 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 2016-06-17.
- Submission: K152771
- Applicant / Sponsor: Sumitomo Bakelite Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2016-06-17
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.