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FDA 510(k)

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

K-Number: K182066 · 2018-10-30

ApplicantCook Incorporated
Decision Date2018-10-30
Product CodeKOB
Advisory CommitteeGU
DecisionUnknown

Device Summary

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-10-30 under approval number K182066. 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 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is a medical device that received FDA 510(k) clearance on 2018-10-30. It is manufactured by Cook Incorporated. The 510(k) number is K182066.

When was O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set approved by the FDA?

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set received FDA 510(k) clearance on 2018-10-30, under approval number K182066.

What company makes O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is manufactured by Cook Incorporated.

What is the FDA product code for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

The FDA product code for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set 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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