Clearance Summary
T-TUBE INSERTER received FDA 510(k) clearance under submission number K870978, sponsored by Sur-Med Instruments, 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 1987-03-19.
- Submission: K870978
- Applicant / Sponsor: Sur-Med Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1987-03-19
Classification & Regulation
This clearance is catalogued under FDA product code JYM and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.