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FDA 510(k)

URINARY DIVERSION EVACUATING CATHETER

K-Number: K914692 · 1992-07-02

ApplicantCook Urological, Inc.
Decision Date1992-07-02
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY DIVERSION EVACUATING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K914692. The device is classified under product code EXD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY DIVERSION EVACUATING CATHETER?

URINARY DIVERSION EVACUATING CATHETER is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Cook Urological, Inc.. The 510(k) number is K914692.

When did URINARY DIVERSION EVACUATING CATHETER receive FDA 510(k) clearance?

URINARY DIVERSION EVACUATING CATHETER received FDA 510(k) clearance on 1992-07-02, under 510(k) number K914692.

Who is the listed applicant for URINARY DIVERSION EVACUATING CATHETER?

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

What is the FDA product code for URINARY DIVERSION EVACUATING CATHETER?

The FDA product code for URINARY DIVERSION EVACUATING CATHETER is EXD.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: EXD)

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.

K121833OSTOMY IRRIGATION SETColoplast A/SK904586PALEX IRRIGATION SETPalex Intl. SAK871791BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & HartsonK840268IRRIGATION SYSTEMColoplast A/SK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & SonsK823274UNI-TIP COLOSTOMY IRRIGATION CONEHowmedica Corp.

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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