510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925608Unknown

Scimed Encore(tm) Advantage Kit/essentials Kit

Scimed Life Systems, Inc., Maple Grove MN / Traditional, Unknown
FDA source (opens on fda.gov)

K925608 is the FDA 510(k) clearance record for SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code MFY (Endothelial Cell Harvesting Kit). FDA's definition for product code MFY reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K925608.

Clearance record

Decision date
Received
(223 days to decision)
Product code
MFY Endothelial Cell Harvesting Kit
Regulation
21 CFR 870.4075
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 6655 Wedgwood Rd., Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code MFY

Trailing 12 months

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

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