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FDA 510(k)

NCompass Nitinol Stone Extractors

K-Number: K173009 · 2017-11-07

ApplicantCook Incorporated
Decision Date2017-11-07
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NCompass Nitinol Stone Extractors is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K173009. 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 NCompass Nitinol Stone Extractors?

NCompass Nitinol Stone Extractors is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is Cook Incorporated. The 510(k) number is K173009.

When did NCompass Nitinol Stone Extractors receive FDA 510(k) clearance?

NCompass Nitinol Stone Extractors received FDA 510(k) clearance on 2017-11-07, under 510(k) number K173009.

Who is the listed applicant for NCompass Nitinol Stone Extractors?

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 NCompass Nitinol Stone Extractors?

The FDA product code for NCompass Nitinol Stone Extractors is LQR.

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Related Devices (Code: LQR)

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.

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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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