Clearance Summary
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES received FDA 510(k) clearance under submission number K940903, sponsored by Medical Insights, 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 1994-04-14.
- Submission: K940903
- Applicant / Sponsor: Medical Insights, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1994-04-14
Classification & Regulation
This clearance is catalogued under FDA product code KBM and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.