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FDA 510(k)

Nathanson Transcystic Bile Duct Stone Exploration Pack

K-Number: K171915 · 2018-03-01

ApplicantCook Incorporated
Decision Date2018-03-01
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nathanson Transcystic Bile Duct Stone Exploration Pack is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-03-01 under 510(k) number K171915. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nathanson Transcystic Bile Duct Stone Exploration Pack?

Nathanson Transcystic Bile Duct Stone Exploration Pack is a medical device that received FDA 510(k) clearance on 2018-03-01. The listed applicant is Cook Incorporated. The 510(k) number is K171915.

When did Nathanson Transcystic Bile Duct Stone Exploration Pack receive FDA 510(k) clearance?

Nathanson Transcystic Bile Duct Stone Exploration Pack received FDA 510(k) clearance on 2018-03-01, under 510(k) number K171915.

Who is the listed applicant for Nathanson Transcystic Bile Duct Stone Exploration Pack?

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 Nathanson Transcystic Bile Duct Stone Exploration Pack?

The FDA product code for Nathanson Transcystic Bile Duct Stone Exploration Pack is LQR.

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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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