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FDA 510(k)

Wittich Nitinol Stone Basket

K-Number: K170898 · 2017-12-12

ApplicantCook Incorporated
Decision Date2017-12-12
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Wittich Nitinol Stone Basket is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K170898. 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 Wittich Nitinol Stone Basket?

Wittich Nitinol Stone Basket is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Cook Incorporated. The 510(k) number is K170898.

When did Wittich Nitinol Stone Basket receive FDA 510(k) clearance?

Wittich Nitinol Stone Basket received FDA 510(k) clearance on 2017-12-12, under 510(k) number K170898.

Who is the listed applicant for Wittich Nitinol Stone Basket?

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 Wittich Nitinol Stone Basket?

The FDA product code for Wittich Nitinol Stone Basket 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.

K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation

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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