510(k) · Decided

Recalled · Class II · 2026

Strange Bile Duct Stone Exploration Set

K173687510(k) TraditionalDecided Dec 15, 201714-day reviewClass II21 CFR 876.5010Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Incorporated · LQR Dislodger, Stone, Biliary

Cleared on Dec 15, 2017 as substantially equivalent to K173009 (Cook Incorporated, 2017) after a 14-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.

Decided: Dec 15, 2017
Review: 14 days
Class: Class II
Product code: LQR
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K902944 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK902944 Wittich Nitinol Stone BasketCook, Inc. · 1990
1 generation backK173009 NCompass Nitinol Stone ExtractorsCook Incorporated · 2017 · Recalled
This deviceK173687 Strange Bile Duct Stone Exploration SetCook Incorporated · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K902944	Wittich Nitinol Stone Basket	Cook, Inc.	1990	—
−1	K173009	NCompass Nitinol Stone Extractors	Cook Incorporated	2017	1
0 (this device)	K173687	Strange Bile Duct Stone Exploration Set	Cook Incorporated	2017	—

FIG. 1 — Lineage of K173687, 1990–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LQR device

#1 K253056 Disposable Stone Extraction Basketscore 11.7 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K173009	NCompass Nitinol Stone Extractors Summary page 4 …ries Primary Product Code: LQR Secondary Product Codes: GCD, GBZ, OCY, GCB Predicate Devices: The predicate device is the NCompass Nitinol Stone Extractor (K173009). Device Description: The Strange Bile Duct Stone Exploration Set is provided sterile for single-use only. The set consists of:…	Cook Incorporated	2017	1

Also cleared against K173009: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 5, 2026	Class II	Z-1784-2026	Incorrect or no expiration date	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 27.2 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K173009.

How does its category compare?

All LQR devices

LQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LQR

1in 2025

2007high 4 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQR

248in 2018

2007high 248 (2018) · low 148 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LQR

3in 2009

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LQR

111in 2025

2007high 111 (2025) · low 4 (2008)2025

MAUDE reports naming product code LQR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	23
2008	0	—	0	4
2009	2	—	3	28
2010	0	—	0	39
2011	0	—	0	47
2012	0	—	0	50
2013	1	—	0	13
2014	0	—	0	21
2015	0	—	0	12
2016	0	—	0	4
2017	4	148	0	11
2018	3	248	0	43
2019	1	—	0	41
2020	1	—	0	51
2021	1	—	0	47
2022	0	—	0	58
2023	1	—	0	71
2024	2	—	0	69
2025	1	—	0	111
2026	1	—	0	—

What is it indicated for?

The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173687 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173687: Strange Bile Duct Stone Exploration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173687

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026