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FDA 510(k)

One-Step Suprapubic Introducer

K-Number: K182709 · 2018-12-26

ApplicantCook Incorporated
Decision Date2018-12-26
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

One-Step Suprapubic Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-12-26 under 510(k) number K182709. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One-Step Suprapubic Introducer?

One-Step Suprapubic Introducer is a medical device that received FDA 510(k) clearance on 2018-12-26. The listed applicant is Cook Incorporated. The 510(k) number is K182709.

When did One-Step Suprapubic Introducer receive FDA 510(k) clearance?

One-Step Suprapubic Introducer received FDA 510(k) clearance on 2018-12-26, under 510(k) number K182709.

Who is the listed applicant for One-Step Suprapubic Introducer?

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 One-Step Suprapubic Introducer?

The FDA product code for One-Step Suprapubic Introducer is KOB.

Other records listing Cook Incorporated as applicant

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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.K181097Cook Cystostomy Catheter SetCook 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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