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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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-12-26 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K182709.

When was One-Step Suprapubic Introducer approved by the FDA?

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

What company makes One-Step Suprapubic Introducer?

One-Step Suprapubic Introducer is manufactured by Cook Incorporated.

What is the FDA product code for One-Step Suprapubic Introducer?

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

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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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