Clearance Summary
DISPOSABLE ENT PUNCH received FDA 510(k) clearance under submission number K942065, sponsored by United States Surgical, A Division of Tyco Healthc. 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 1994-06-06.
- Submission: K942065
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1994-06-06
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.