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FDA 510(k)

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle

K-Number: K183035 · 2019-05-17

ApplicantCook Incorporated
Decision Date2019-05-17
Product CodeLJE
DecisionUnknown

Device Summary

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K183035. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Cook Incorporated. The 510(k) number is K183035.

When did Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle receive FDA 510(k) clearance?

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle received FDA 510(k) clearance on 2019-05-17, under 510(k) number K183035.

Who is the listed applicant for Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

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 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

The FDA product code for Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is LJE.

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Related Devices (Code: LJE)

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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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