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FDA 510(k)

UNIVERSAL URETHRAL CATHETER

K-Number: K946282 · 1995-03-31

ApplicantLouisville Laboratories, Inc.
Decision Date1995-03-31
Product CodeEZC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1995-03-31 under 510(k) number K946282. The device is classified under product code EZC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL URETHRAL CATHETER?

UNIVERSAL URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K946282.

When did UNIVERSAL URETHRAL CATHETER receive FDA 510(k) clearance?

UNIVERSAL URETHRAL CATHETER received FDA 510(k) clearance on 1995-03-31, under 510(k) number K946282.

Who is the listed applicant for UNIVERSAL URETHRAL CATHETER?

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

What is the FDA product code for UNIVERSAL URETHRAL CATHETER?

The FDA product code for UNIVERSAL URETHRAL CATHETER is EZC.

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Other records listing Louisville Laboratories, 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.

K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETK971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSK971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONK971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONK971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITK971801LAPAROTOMY BLADDER NECK SUSPENSION KIT

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Related Devices (Code: EZC)

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.

K222279Rusch Intermittent Urethral CathetersTeleflex MedicalK173596Rusch Intermittent Urethral CathetersTeleflex MedicalK913341BARD(R) COUDE TIP TEMPERATURE SENSING CATHETERC.R. Bard, Inc.K910846BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIFC.R. Bard, Inc.K910197HYDROGEL-COATED URETHRAL CATHETERS AND DRAINSC.R. Bard, Inc.K910195BARD HYDROGEL-COATED FOLEY CATHETERSC.R. Bard, 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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