510(k) K192418
K192418 is an FDA 510(k) premarket notification submitted by Raico, LLC for the device "Phacoemulsification Needle (Tip) and Irrigation Sleeve". The FDA issued a decision of Substantially Equivalent on May 27, 2020. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2020
- Date Received
- September 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type