FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iPrime Viscodelivery System
K Number: K212797
·
Decision Jan 6, 2022
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
1
Review Days
126
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Basic Information
- Device Name
- iPrime Viscodelivery System
- K Number
- K212797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Glaukos
- Date Received
- September 2, 2021
- Decision Date
- January 6, 2022
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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