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FDA 510(k)

URETHRAL BALLOON DILATION CATHETER SET

K-Number: K892855 · 1989-11-17

ApplicantCook Urological, Inc.
Decision Date1989-11-17
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL BALLOON DILATION CATHETER SET 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 1989-11-17 under 510(k) number K892855. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETHRAL BALLOON DILATION CATHETER SET?

URETHRAL BALLOON DILATION CATHETER SET is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Cook Urological, Inc.. The 510(k) number is K892855.

When did URETHRAL BALLOON DILATION CATHETER SET receive FDA 510(k) clearance?

URETHRAL BALLOON DILATION CATHETER SET received FDA 510(k) clearance on 1989-11-17, under 510(k) number K892855.

Who is the listed applicant for URETHRAL BALLOON DILATION CATHETER SET?

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 URETHRAL BALLOON DILATION CATHETER SET?

The FDA product code for URETHRAL BALLOON DILATION CATHETER SET is KOE.

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Other records listing Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical 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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