510(k) · Cleared

Cleared

Climber - Partially Coated Guide Wire for Endoscopic Use

K971937510(k) TraditionalCleared Aug 15, 199780-day reviewClass II21 CFR 876.1500

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

Terumo Medical Corp. · OCY Endoscopic Guidewire, Gastroenterology-Urology

Cleared on Aug 15, 1997 as substantially equivalent to K910722 (Terumo Corp., 1991) after an 80-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.

Decided: Aug 15, 1997
Review: 80 days
Class: Class II
Product code: OCY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K910722 (1991). 11 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK910722 450CM Guide Wire for G.I. UseTerumo Corp. · 1991
This deviceK971937 Climber - Partially Coated Guide Wire for Endoscopic UseTerumo Medical Corp. · 1997
Descendant · cites it directly · 10 of its ownK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
Descendant · 2 generations on · 8 of its ownK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
Descendant · 3 generations on · 7 of its ownK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
Descendant · 4 generations on · 4 of its ownK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015 · Recalled
Descendant · 5 generations on · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002high 2 (2015) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all

K021179Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002 · cites it directly10descendants
K091417Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A…Terumo Corp. · 2009 · 2 generations on8descendants
K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013 · 3 generations on7descendants
K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 2015 · 4 generations on4descendants
K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910722	450CM Guide Wire for G.I. Use	Terumo Corp.	1991	—
0 (this device)	K971937	Climber - Partially Coated Guide Wire for Endoscopic Use	Terumo Medical Corp.	1997	—
+1	K021179	Disposable Guidewire, Models G-205-3545S & G-205-3545A	Olympus Optical Co., Ltd.	2002	—
+2	K091417	Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…	Terumo Corp.	2009	—
+3	K122505	Single Use Preloaded Sphincterotome V	Olympus Medical Systems Corp.	2013	—
+4	K141991	Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP	Olympus Medical Systems Copr.	2015	3
+5	K192339	TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord	Wilson-Cook Medical, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2007	1	0
2009	1	0
2013	1	0
2015	2	0
2016	1	0
2019	1	0
2020	1	0
2025	2	0

FIG. 1 — Lineage of K971937, 1991–2025Source: 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 OCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K910722	450CM Guide Wire for G.I. Use Summary page 1 …nsertion into bile duct strictures and pancreatic duct strictures. Note: This is the same intended use as the Terumo 450 cm Guide Wire for G.I. Use cleared under 510(k) K910722. DESCRIPTION The CLIMBER has a core of titanium nickel alloy coated with polyurethane. The distal tip up to 150 cm is coated ag…	Terumo Corp.	1991	—
*	—	Microvasive GEENEN ENDOTORQUE™ Guide Wire Named without a submission number			—
*	—	WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip Named without a submission number			—

Also cleared against K910722: 1 other device →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K021179	Disposable Guidewire, Models G-205-3545S & G-205-3545A	Olympus Optical Co., Ltd.	2002	10

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, K021179 (Olympus Optical Co., Ltd., 2002) has gone furthest, with 10 descendants of its own.
1 other device also cites its predicate K910722.

How does its category compare?

All OCY devices

OCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCY

1in 2016

2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCY

51in 2015

2007high 60 (2013) · low 41 (2014)2026

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

Recalls per year · OCY

8in 2019

2007high 8 (2019) · low 0 (2007)2026

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

Adverse event reports per year · OCY

133in 2025

2007high 283 (2015) · low 1 (2012)2025

MAUDE reports naming product code OCY, 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	3
2008	3	55	0	7
2009	1	—	0	7
2010	0	—	0	9
2011	0	—	0	3
2012	2	—	0	1
2013	4	60	0	32
2014	5	41	0	51
2015	3	51	0	283
2016	1	—	0	158
2017	0	—	0	85
2018	0	—	0	101
2019	0	—	8	103
2020	0	—	0	128
2021	0	—	0	94
2022	0	—	0	134
2023	0	—	0	115
2024	0	—	0	131
2025	0	—	0	133
2026	0	—	0	—

What is it indicated for?

The CLIMBER - Partially Coated Guide Wire for Endoscopic Use is designed for endoscopic use. The CLIMBER is used for supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971937 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971937: Climber - Partially Coated Guide Wire for Endoscopic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971937

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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