Clearance Summary
Disposable Laryngeal Electrodes received FDA 510(k) clearance under submission number K232888, sponsored by Suzhou Haishen Medical Device Associates Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2023-12-21.
- Submission: K232888
- Applicant / Sponsor: Suzhou Haishen Medical Device Associates Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2023-12-21
Classification & Regulation
This clearance is catalogued under FDA product code ETN and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.