510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223074Substantially Equivalent

CorNeat EverPatch

Corneat Vision, Ltd., Raanana, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223074 is the FDA 510(k) clearance record for CorNeat EverPatch, a class II device, cleared for Corneat Vision , Ltd. on under FDA product code QWU (Prosthesis, Eyelid Spacer/Graft, Polymer). FDA's definition for product code QWU reads: "For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area". FDA records list one 510(k) clearance for Corneat Vision , Ltd. As of , FDA records show 3 recalls naming K223074.

Clearance record

Decision date
Received
(245 days to decision)
Product code
QWU Prosthesis, Eyelid Spacer/Graft, Polymer
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Corneat Vision , Ltd. 4 Hasheyzaf St., Raanana, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWU

Trailing 12 months

FDA records hold no clearances under product code QWU in the trailing twelve months.

FDA records show no clearances under product code QWU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260