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FDA 510(k)

GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES

K-Number: K011120 · 2001-05-08

ApplicantNipro Diabetes Systems, Inc.
Decision Date2001-05-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES 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 2001-05-08 under 510(k) number K011120. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES?

GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Nipro Diabetes Systems, Inc.. The 510(k) number is K011120.

When did GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES receive FDA 510(k) clearance?

GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES received FDA 510(k) clearance on 2001-05-08, under 510(k) number K011120.

Who is the listed applicant for GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES?

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 INFUSION SET, MODEL GPISXXXXXXXX SERIES?

The FDA product code for GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES is FPA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-XXXXXXXXK013309GLUCOPRO EVO INFUSION PUMP

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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