Clearance Summary
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION received FDA 510(k) clearance under submission number K934320, sponsored by Mentor O & O, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-02-16.
- Submission: K934320
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4100
- Decision date: 1994-02-16
Classification & Regulation
This clearance is catalogued under FDA product code HQR and 21 CFR 886.4100, within the Ophthalmic review panel as a Class II device.