Clearance Summary
ILS(TM) - INVASIVE LINE SEPARATOR received FDA 510(k) clearance under submission number K924369, sponsored by 2-Rn Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-02-05.
- Submission: K924369
- Applicant / Sponsor: 2-Rn Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1993-02-05
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.