FDA 510(k)

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY

K-Number: K962073 · 1996-06-21

ApplicantContinental Medical Laboratories, Inc.

Decision Date1996-06-21

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Continental Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K962073. 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/UNIVERSAL URETHRAL CATH TRAY?

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Continental Medical Laboratories, Inc.. The 510(k) number is K962073.

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

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY received FDA 510(k) clearance on 1996-06-21, under 510(k) number K962073.

Who is the listed applicant for URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY?

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

What is the FDA product code for URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY?

The FDA product code for URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY is FCM.

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Other records listing Continental Medical Laboratories, Inc. as applicant

K964827PROD. NO. 01-132 - SUTURE REMOVAL KIT K963234STAPLE REMOVAL KIT K963443PROD. NO. 02-031 - LACERATION TRAY K962078TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER K954728PROD NO. 01-1694 - 4X4 FOAM DRESSING K952335WOUND CARE MANAGEMENT KITS

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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.