DeviceClearance

Product code QWU— Ophthalmic

CorNeat EverPatch

Classification name
Prosthesis, Eyelid Spacer/Graft, Polymer
Device class
Class 2
Regulation
21 CFR 886.3130
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.”

— U.S. Food and Drug Administration, device classification record for product code QWU under 21 CFR 886.3130, via openFDA

Market context for product code QWU

FDA has cleared 1 device under product code QWU, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWU

Recent clearances under product code QWU

Data sourced from openFDA. This site is unofficial and independent of the FDA.