510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QCWClass II

Corneal Storage Media With Preservatives Including Anti-Fungal

21 CFR 886.4320 / Ophthalmic
FDA source (opens on fda.gov)

QCW is the FDA product code for Corneal Storage Media With Preservatives Including Anti-Fungal, a class II device type, regulated under 21 CFR 886.4320. FDA's definition for this code reads: "Media to preserve human corneas while in storage". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QCW
Device name
Corneal Storage Media With Preservatives Including Anti-Fungal
FDA definition
Media to preserve human corneas while in storage.
Regulation
21 CFR 886.4320
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QCW

By decision year
1 clearance under product code QCW with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCW by decision year
YearClearances
20221

Applicants with the most clearances

Product code QCW
Applicants holding the most 510(k) clearances under product code QCW
ApplicantClearances
Al.chi.mi.a. SRL1

Companies listing this code with FDA

Companies whose registered establishments list this code