Wittich Nitinol Stone Basket— 510(k) K170898

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K170898 for Wittich Nitinol Stone Basket, Substantially Equivalent on 2017-12-12. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2017-03-27
Decision date: 2017-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQR

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K230598 — Stone Extraction Baskets2023-09-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.