Clearance Summary
Bi-Blade Vitrectomy Cutter received FDA 510(k) clearance under submission number K153168, sponsored by Medical Instrument Development Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2016-04-29.
- Submission: K153168
- Applicant / Sponsor: Medical Instrument Development Laboratories
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 2016-04-29
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.