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FDA 510(k)

URETHRAL CATHETERIZATION TRAY

K-Number: K950390 · 1995-05-30

ApplicantMedcare Custom Packaging, Inc.
Decision Date1995-05-30
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K950390. 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 URETHRAL CATHETERIZATION TRAY?

URETHRAL CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K950390.

When did URETHRAL CATHETERIZATION TRAY receive FDA 510(k) clearance?

URETHRAL CATHETERIZATION TRAY received FDA 510(k) clearance on 1995-05-30, under 510(k) number K950390.

Who is the listed applicant for URETHRAL CATHETERIZATION TRAY?

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

What is the FDA product code for URETHRAL CATHETERIZATION TRAY?

The FDA product code for URETHRAL CATHETERIZATION TRAY is FCM.

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Other records listing Medcare Custom Packaging, 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.

K954869MEDCARE YANKAUER SUCTION DEVICEK954442STERILE ISOTONIC SALINE & STERILE WATERK952759TOWEL PACKK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK951149SINGLE USE INSTRUMENT TRAYK934732PELVIC EXAM TRAY

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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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