Clearance Summary
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 received FDA 510(k) clearance under submission number K980399, sponsored by Peregrine Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-04-30.
- Submission: K980399
- Applicant / Sponsor: Peregrine Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1998-04-30
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.