CorNeat EverPatch— 510(k) K223074
Substantially EquivalentCorneat Vision , Ltd.
FDA 510(k) clearance K223074 for CorNeat EverPatch, Substantially Equivalent on 2023-06-02. Applicant: Corneat Vision , Ltd.. Device class: 2.
Clearance details
- Applicant
- Corneat Vision , Ltd.
- Product code
- Code QWU
- Device class
- Class 2
- Regulation
- 21 CFR 886.3130
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raanana, IL
Recalls naming K223074
K-number listed on FDA's recall record- Z-0039-2026 — CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
- Z-0040-2026 — EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
- Z-2537-2025 — CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223074.
Data sourced from openFDA. This site is unofficial and independent of the FDA.