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510(k) K240355

FROG (Filter Removal of Glass) by Carrtech Corp — Product Code FMI

K240355 is an FDA 510(k) premarket notification submitted by Carrtech Corp for the device "FROG (Filter Removal of Glass)". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2025
Date Received
February 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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FDA data resources