510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200063Unknown

Kerasave

Al.chi.mi.a. SRL, Ponte San Nicolò, IT / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN200063 is the FDA 510(k) clearance record for Kerasave, a class II device, cleared for Al.Chi.Mi.A. S.R.L on under FDA product code QCW (Corneal Storage Media With Preservatives Including Anti-Fungal). FDA's definition for product code QCW reads: "Media to preserve human corneas while in storage". FDA records list 5 510(k) clearances for Al.Chi.Mi.A. S.R.L, from to . As of , FDA records show no recalls naming DEN200063.

Clearance record

Decision date
Received
(578 days to decision)
Product code
QCW Corneal Storage Media With Preservatives Including Anti-Fungal
Regulation
21 CFR 886.4320
Device class
Class II
Review panel
Ophthalmic
Applicant
Al.Chi.Mi.A. S.R.L Viale Austria, 14, Ponte San Nicolò, IT
Third party review
No

Clearances, product code QCW

Trailing 12 months

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

FDA records show no clearances under product code QCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCW, 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