FDA 510(k)

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

K-Number: K201936 · 2021-05-06

Decision Date2021-05-06

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is the device name listed in this FDA 510(k) record. The listed applicant is Gilero, LLC. It received FDA 510(k) clearance on 2021-05-06 under 510(k) 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. The listed applicant is Gilero, LLC. The 510(k) number is K201936.

When did SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

The FDA 510(k) record lists Gilero, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Gilero, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

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.