Clearance Summary
Pre-Formed Penile Silicone Block received FDA 510(k) clearance under submission number K181387, sponsored by International Medical Devices, Inc.. 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 2019-01-23.
- Submission: K181387
- Applicant / Sponsor: International Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2019-01-23
Classification & Regulation
This clearance is catalogued under FDA product code MIB and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.