Cleared Traditional

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

K201936 · Gilero, LLC · General Hospital

May 2021

Decision

297d

Days

Class 2

Risk

About This 510(k) Submission

K201936 is an FDA 510(k) clearance for the SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Gilero, LLC (Morrisville, US). The FDA issued a Cleared decision on May 6, 2021, 297 days after receiving the submission on July 13, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number	K201936 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2020
Decision Date	May 06, 2021
Days to Decision	297 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF