Clearance Summary
Endotracheal Tube with Evacuation Lumen received FDA 510(k) clearance under submission number K182739, sponsored by Well Lead Medical Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2019-12-11.
- Submission: K182739
- Applicant / Sponsor: Well Lead Medical Co., Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2019-12-11
Classification & Regulation
This clearance is catalogued under FDA product code BTR and 21 CFR 868.5730, within the Anesthesiology review panel as a Class II device.