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FDA 510(k)

GLUCOPRO EVO INFUSION PUMP

K-Number: K013309 · 2002-06-24

ApplicantNipro Diabetes Systems, Inc.
Decision Date2002-06-24
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUCOPRO EVO INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Diabetes Systems, Inc.. It received FDA 510(k) clearance on 2002-06-24 under 510(k) number K013309. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOPRO EVO INFUSION PUMP?

GLUCOPRO EVO INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2002-06-24. The listed applicant is Nipro Diabetes Systems, Inc.. The 510(k) number is K013309.

When did GLUCOPRO EVO INFUSION PUMP receive FDA 510(k) clearance?

GLUCOPRO EVO INFUSION PUMP received FDA 510(k) clearance on 2002-06-24, under 510(k) number K013309.

Who is the listed applicant for GLUCOPRO EVO INFUSION PUMP?

The FDA 510(k) record lists Nipro Diabetes Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOPRO EVO INFUSION PUMP?

The FDA product code for GLUCOPRO EVO INFUSION PUMP is LZG.

Related Clinical Trials

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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Other records listing Nipro Diabetes Systems, Inc. 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.

K071613AMIGO INSULIN PUMPK050312AMIGO INSULIN PUMPK014114GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXXK011120GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

Official Source

View on FDA Database →

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

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