Certas Plus Programmable Valves
FDA 510(k) clearance K223330 · decided 2023-02-01
Clearance details
- K-number
- K223330
- Device name
- Certas Plus Programmable Valves
- Applicant
- Integra Lifesciences Production Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-10-31
- Decision date
- 2023-02-01
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Imp recall (Z-0978-2025) | Integra LifeSciences Corp. | 2025-01-17 |