FDA 510(k)

AMSELF CLOSED CATHETERIZATION SYSTEM

K-Number: K082831 · 2008-10-23

Decision Date2008-10-23

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AMSELF CLOSED CATHETERIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2008-10-23 under 510(k) number K082831. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSELF CLOSED CATHETERIZATION SYSTEM?

AMSELF CLOSED CATHETERIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is Amsino International, Inc.. The 510(k) number is K082831.

When did AMSELF CLOSED CATHETERIZATION SYSTEM receive FDA 510(k) clearance?

AMSELF CLOSED CATHETERIZATION SYSTEM received FDA 510(k) clearance on 2008-10-23, under 510(k) number K082831.

Who is the listed applicant for AMSELF CLOSED CATHETERIZATION SYSTEM?

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

What is the FDA product code for AMSELF CLOSED CATHETERIZATION SYSTEM?

The FDA product code for AMSELF CLOSED CATHETERIZATION SYSTEM is FCM.

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Other records listing Amsino International, Inc. as applicant

K252543AMSafe 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)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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Related Devices (Code: FCM)

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec Limited K223821Self-Cath Closed SystemColoplast K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLC K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.K030712AMSURE URETHRAL CATHETERIZATION TRAYAmsino International, 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.