DeviceClearance

Product code QCW— Ophthalmic

Kerasave

Classification name
Corneal Storage Media With Preservatives Including Anti-Fungal
Device class
Class 2
Regulation
21 CFR 886.4320
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“Media to preserve human corneas while in storage.”

— U.S. Food and Drug Administration, device classification record for product code QCW under 21 CFR 886.4320, via openFDA

Market context for product code QCW

FDA has cleared 1 device under product code QCW, all in 2022, 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 QCW

Recent clearances under product code QCW

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