CorNeat EverPatch
FDA 510(k) clearance K223074 · decided 2023-06-02
Clearance details
- K-number
- K223074
- Device name
- CorNeat EverPatch
- Applicant
- Corneat Vision , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-30
- Decision date
- 2023-06-02
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- QWU
- Device class
- 2
- Regulation number
- 886.3130
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Raanana, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 60 recall (Z-0039-2026) | CORNEAT VISION, LTD. | 2025-10-03 |
| EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 recall (Z-0040-2026) | CORNEAT VISION, LTD. | 2025-10-03 |
| CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6. recall (Z-2537-2025) | CORNEAT VISION, LTD. | 2025-09-05 |