Clearance Summary
REPROCESSED DISPOSABLE TROCARS received FDA 510(k) clearance under submission number K022743, sponsored by Medical Device Services. 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 2002-10-09.
- Submission: K022743
- Applicant / Sponsor: Medical Device Services
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2002-10-09
Classification & Regulation
This clearance is catalogued under FDA product code KAB and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.