Clearance Summary
REPROCESSED DISPOSABLE TROCARS received FDA 510(k) clearance under submission number K013987, sponsored by Adven Medical. 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 2002-03-01.
- Submission: K013987
- Applicant / Sponsor: Adven Medical
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2002-03-01
Classification & Regulation
This clearance is catalogued under FDA product code KBG and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.