Clearance Summary
GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) received FDA 510(k) clearance under submission number K890782, sponsored by Grieshaber & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-06-23.
- Submission: K890782
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.