Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

K-Number: K172278 · 2017-11-22

ApplicantCook Incorporated
Decision Date2017-11-22
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172278. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Cook Incorporated. The 510(k) number is K172278.

When did Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent receive FDA 510(k) clearance?

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172278.

Who is the listed applicant for Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

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

What is the FDA product code for Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent?

The FDA product code for Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent is GBM.

Other records listing Cook Incorporated 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.

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo Introducer

View all 147 devices →

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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.

↑