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FDA 510(k)

MENTOR SELF-CATH CLOSED SYSTEM

K-Number: K003873 · 2001-03-29

ApplicantMentor Corp.
Decision Date2001-03-29
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR SELF-CATH CLOSED SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2001-03-29 under 510(k) number K003873. 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 MENTOR SELF-CATH CLOSED SYSTEM?

MENTOR SELF-CATH CLOSED SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-29. The listed applicant is Mentor Corp.. The 510(k) number is K003873.

When did MENTOR SELF-CATH CLOSED SYSTEM receive FDA 510(k) clearance?

MENTOR SELF-CATH CLOSED SYSTEM received FDA 510(k) clearance on 2001-03-29, under 510(k) number K003873.

Who is the listed applicant for MENTOR SELF-CATH CLOSED SYSTEM?

The FDA 510(k) record lists Mentor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR SELF-CATH CLOSED SYSTEM?

The FDA product code for MENTOR SELF-CATH CLOSED SYSTEM is FCM.

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Other records listing Mentor Corp. as applicant

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K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: FCM)

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.

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 LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN 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.

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