Cleared Traditional

Surflo Winged Infusion Set

K221411 · Terumo Medical Products Hangzhou Co., Ltd. · General Hospital
Jun 2023
Decision
403d
Days
Class 2
Risk

About This 510(k) Submission

K221411 is an FDA 510(k) clearance for the Surflo Winged Infusion Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 23, 2023, 403 days after receiving the submission on May 16, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K221411 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2022
Decision Date June 23, 2023
Days to Decision 403 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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