Clearance Summary
SureClip(TM) Repositionable Hemostasis Clip received FDA 510(k) clearance under submission number K161463, sponsored by Micro-Tech (Nanjing) 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 2017-01-06.
- Submission: K161463
- Applicant / Sponsor: Micro-Tech (Nanjing) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2017-01-06
Classification & Regulation
This clearance is catalogued under FDA product code PKL and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.