Clearance Summary
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) received FDA 510(k) clearance under submission number K231725, sponsored by Hunan Endoso Life Technology 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 2023-10-16.
- Submission: K231725
- Applicant / Sponsor: Hunan Endoso Life Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-10-16
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.