Clearance Summary
MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES received FDA 510(k) clearance under submission number K936247, sponsored by Medicon Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-05-19.
- Submission: K936247
- Applicant / Sponsor: Medicon Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 1994-05-19
Classification & Regulation
This clearance is catalogued under FDA product code DRC and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.