Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIMPLICITY SIMPLEX SOFT INFUSION SET

K-Number: K020629 · 2002-04-01

ApplicantSterling Medivations, Inc.
Decision Date2002-04-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIMPLICITY SIMPLEX SOFT INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Medivations, Inc.. It received FDA 510(k) clearance on 2002-04-01 under 510(k) number K020629. 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 SIMPLICITY SIMPLEX SOFT INFUSION SET?

SIMPLICITY SIMPLEX SOFT INFUSION SET is a medical device that received FDA 510(k) clearance on 2002-04-01. The listed applicant is Sterling Medivations, Inc.. The 510(k) number is K020629.

When did SIMPLICITY SIMPLEX SOFT INFUSION SET receive FDA 510(k) clearance?

SIMPLICITY SIMPLEX SOFT INFUSION SET received FDA 510(k) clearance on 2002-04-01, under 510(k) number K020629.

Who is the listed applicant for SIMPLICITY SIMPLEX SOFT INFUSION SET?

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

What is the FDA product code for SIMPLICITY SIMPLEX SOFT INFUSION SET?

The FDA product code for SIMPLICITY SIMPLEX SOFT INFUSION SET 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 Sterling Medivations, 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.

K021530SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKINK021487SIMPLICITY EASY ACCESS P INFUSION SETK021296SIMPLICITY QD EASY P INFUSION SETK021216SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPSK021005SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACEK020912SIMPLICITY EASY SOFT INFUSION SET

View all 27 devices →

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

View on FDA Database →

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

↑