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FDA 510(k)

BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER

K-Number: K041464 · 2004-11-05

ApplicantBusse Hospital Disposables
Decision Date2004-11-05
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables. It received FDA 510(k) clearance on 2004-11-05 under 510(k) number K041464. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER?

BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is Busse Hospital Disposables. The 510(k) number is K041464.

When did BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER receive FDA 510(k) clearance?

BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER received FDA 510(k) clearance on 2004-11-05, under 510(k) number K041464.

Who is the listed applicant for BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER?

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

What is the FDA product code for BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER?

The FDA product code for BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER is EZD.

Related Clinical Trials

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.

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Other records listing Busse Hospital Disposables 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.

K110883J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULAK093920BUSSE EPIDURAL CATHETER KIT

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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