FDA 510(k)

AMSURE FOLEY INSERTION TRAY

K-Number: K030664 · 2003-05-23

Decision Date2003-05-23

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AMSURE FOLEY INSERTION TRAY 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 2003-05-23 under 510(k) number K030664. 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 AMSURE FOLEY INSERTION TRAY?

AMSURE FOLEY INSERTION TRAY is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Amsino International, Inc.. The 510(k) number is K030664.

When did AMSURE FOLEY INSERTION TRAY receive FDA 510(k) clearance?

AMSURE FOLEY INSERTION TRAY received FDA 510(k) clearance on 2003-05-23, under 510(k) number K030664.

Who is the listed applicant for AMSURE FOLEY INSERTION TRAY?

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 AMSURE FOLEY INSERTION TRAY?

The FDA product code for AMSURE FOLEY INSERTION TRAY is FCM.

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Other records listing Amsino International, Inc. as applicant

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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 K082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLC K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, 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.