510(k) · Cleared

Cleared

Zimmon Needle Knife Papillotome

K171993510(k) TraditionalCleared Aug 17, 201745-day reviewClass II21 CFR 876.4300

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

Wilson-Cook Medical Inc./Cook Endoscopy · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Aug 17, 2017 as substantially equivalent to K972674 (Wilson-Cook Medical, Inc., 1997) after a 45-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Aug 17, 2017
Review: 45 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972674 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK972674 Wilson-Cook Needle Knife PapillotomeWilson-Cook Medical, Inc. · 1997
This deviceK171993 Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy · 2017
Descendant · cites it directly · 0 of its ownK252889 Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation · 2025

Most influential descendants

Showing 1 of 1 · See all

K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972674	Wilson-Cook Needle Knife Papillotome	Wilson-Cook Medical, Inc.	1997	—
0 (this device)	K171993	Zimmon Needle Knife Papillotome	Wilson-Cook Medical Inc./Cook Endoscopy	2017	—
+1	K252889	Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)	Olympus Medical Systems Corporation	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K171993, 1997–2025Source: 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 KNS? 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 KNS device

#1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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
*	K972674	Wilson-Cook Needle Knife Papillotome Summary page 4 …Class II Review Panel: Gastroenterology-Urology Predicate Device Name: Wilson-Cook Needle Knife Papillotome 510(k) Number: K972674 Date: Cleared August 15, 1997 Device Description The Zimmon Needle Knife Papillotome (subject device) is a ste…	Wilson-Cook Medical, Inc.	1997	—

Also cleared against K972674: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K252889	Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)	Olympus Medical Systems Corporation	2025	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K252889 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K972674.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · KNS

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007high 41 (2021) · low 0 (2010)2026

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

Adverse event reports per year · KNS

1,504in 2025

2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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	—	3	164
2008	3	61	5	587
2009	3	212	2	1,027
2010	4	168	0	908
2011	1	—	2	860
2012	2	—	0	848
2013	2	—	0	449
2014	1	—	0	405
2015	3	252	0	406
2016	3	30	6	457
2017	3	48	1	446
2018	5	62	0	563
2019	7	66	0	668
2020	4	212	0	906
2021	4	139	41	814
2022	3	182	0	913
2023	9	83	0	976
2024	3	198	14	1,533
2025	11	171	0	1,504
2026	2	—	4	—

What is it indicated for?

These devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171993 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171993: Zimmon Needle Knife Papillotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171993

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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