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FDA 510(k)

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

K-Number: K201936 · 2021-05-06

ApplicantGilero, LLC
Decision Date2021-05-06
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is a medical device manufactured by Gilero, LLC. It received FDA 510(k) clearance on 2021-05-06 under approval number K201936. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is a medical device that received FDA 510(k) clearance on 2021-05-06. It is manufactured by Gilero, LLC. The 510(k) number is K201936.

When was SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL approved by the FDA?

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL received FDA 510(k) clearance on 2021-05-06, under approval number K201936.

What company makes SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is manufactured by Gilero, LLC.

What is the FDA product code for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

The FDA product code for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is KPE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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