Clearance Summary
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing received FDA 510(k) clearance under submission number K221310, sponsored by Changzhou Endoclean Medical Device 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 2022-10-07.
- Submission: K221310
- Applicant / Sponsor: Changzhou Endoclean Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-10-07
Classification & Regulation
This clearance is catalogued under FDA product code OCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.