Clearance Summary
TRIMOTION INJECTOR received FDA 510(k) clearance under submission number K102999, sponsored by Kaneka Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-12-29.
- Submission: K102999
- Applicant / Sponsor: Kaneka Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2011-12-29
Classification & Regulation
This clearance is catalogued under FDA product code OTZ and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.