NCompass Nitinol Stone Extractors— 510(k) K173009

Name: FDA 510(k) clearance K173009
Creator: U.S. Food and Drug Administration
Published: 2017-11-07

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K173009 for NCompass Nitinol Stone Extractors, Substantially Equivalent on 2017-11-07. 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: 2017-09-27
Decision date: 2017-11-07
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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K253056 — Disposable Stone Extraction Basket2026-04-03
K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P2025-03-18
K243471 — Extraction Basket2024-12-16
K240192 — Single-use Extraction Baskets2024-10-15
K230598 — Stone Extraction Baskets2023-09-12

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Recalls naming K173009

K-number listed on FDA's recall record

Z-1787-2026 — COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.Class II·Ongoing·Cook Incorporated·20260305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173009.

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