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FDA 510(k)

Cook Cystostomy Catheter Set

K-Number: K181097 · 2019-01-18

ApplicantCook Incorporated
Decision Date2019-01-18
Product CodeKOB
Advisory CommitteeGU
DecisionUnknown

Device Summary

Cook Cystostomy Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K181097. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Cook Cystostomy Catheter Set?

Cook Cystostomy Catheter Set is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Cook Incorporated. The 510(k) number is K181097.

When did Cook Cystostomy Catheter Set receive FDA 510(k) clearance?

Cook Cystostomy Catheter Set received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181097.

Who is the listed applicant for Cook Cystostomy Catheter Set?

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 Cook Cystostomy Catheter Set?

The FDA product code for Cook Cystostomy Catheter Set is KOB.

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Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook 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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