Clearance Summary
VENOSCOPE received FDA 510(k) clearance under submission number K941035, sponsored by Trinity Partners, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-05-16.
- Submission: K941035
- Applicant / Sponsor: Trinity Partners, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1945
- Decision date: 1994-05-16
Classification & Regulation
This clearance is catalogued under FDA product code HJN and 21 CFR 886.1945, within the Ophthalmic review panel as a Class I device.