510(k) K212797
K212797 is an FDA 510(k) premarket notification submitted by Glaukos for the device "iPrime Viscodelivery System". The FDA issued a decision of Substantially Equivalent on January 6, 2022. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2022
- Date Received
- September 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type