510(k) · Cleared

Cleared

12 Ureteroscopes/Uretero-Renoscopes

K963855510(k) TraditionalCleared Apr 3, 1997190-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

Richard Wolf Medical Instruments Corp. · FGB Ureteroscope And Accessories, Flexible/Rigid

Cleared on Apr 3, 1997 as substantially equivalent to K940464 (KARL STORZ Endoscopy-America, Inc., 1994) after a 190-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.

Decided: Apr 3, 1997
Review: 190 days
Class: Class II
Product code: FGB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940464 (1994). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK940464 Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc. · 1994
This deviceK963855 12 Ureteroscopes/Uretero-RenoscopesRichard Wolf Medical Instruments Corp. · 1997
Descendant · cites it directly · 0 of its ownK991178 Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac…Richard Wolf Medical Instruments Corp. · 1999
Descendant · cites it directly · 0 of its ownK990050 Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042Richard Wolf Medical Instruments Corp. · 1999

Most influential descendants

Showing 2 of 2 · See all

K991178Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253Richard Wolf Medical Instruments Corp. · 1999 · cites it directly0descendants
K990050Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042Richard Wolf Medical Instruments Corp. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940464	Karl Storz Uretero-Renoscope/Ureterscope	KARL STORZ Endoscopy-America, Inc.	1994	—
0 (this device)	K963855	12 Ureteroscopes/Uretero-Renoscopes	Richard Wolf Medical Instruments Corp.	1997	—
+1	K991178	Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece…	Richard Wolf Medical Instruments Corp.	1999	—
+1	K990050	Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042	Richard Wolf Medical Instruments Corp.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0

FIG. 1 — Lineage of K963855, 1994–1999Source: 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 FGB? 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 FGB device

#1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K940464	Karl Storz Uretero-Renoscope/Ureterscope Summary page 1 …proprietary or model name Manufacturer 1 pre-enact. 1 Cysto-Urethroscope 4616 1 Richard Wolf M.1.C. 2 pre-enact. 2 Cysto-Urethroscope 8616.10 2 Richard Wolf M.I1.C. 3K 94 04 64 3 Slender Uretero-Renoscope 27023AS 3 Storz 4 4 Ureteroscopes Micro-6 / Micro-6 long 4 Circon 5K 94 04 64 5 Operating Uretero-R…	KARL STORZ Endoscopy-America, Inc.	1994	—
*	—	Cysto-Urethroscope 4616 Named without a submission number			—
*	—	Cysto-Urethroscope 8616.10 Named without a submission number			—
*	—	Ureteroscopes Micro-6 / Micro-6 long Named without a submission number			—
*	—	Operating Ureteroscopes MR-7 Series Named without a submission number			—

Also cleared against K940464: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K991178	Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253	Richard Wolf Medical Instruments Corp.	1999	0
K990050	Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042	Richard Wolf Medical Instruments Corp.	1999	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, K991178 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K940464.

How does its category compare?

All FGB devices

FGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGB

17in 2025

2007high 17 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGB

134in 2025

2007high 217 (2024) · low 134 (2025)2026

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

Recalls per year · FGB

15in 2024

2007high 15 (2024) · low 0 (2007)2026

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

Adverse event reports per year · FGB

1,307in 2025

2007high 1,307 (2025) · low 4 (2009)2025

MAUDE reports naming product code FGB, 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	0	—	0	6
2008	0	—	0	7
2009	0	—	0	4
2010	0	—	0	20
2011	0	—	0	17
2012	2	—	0	11
2013	1	—	0	8
2014	2	—	0	12
2015	1	—	0	16
2016	0	—	0	35
2017	2	—	0	142
2018	4	191	0	118
2019	2	—	0	207
2020	2	—	0	402
2021	3	191	0	325
2022	5	205	4	455
2023	8	183	1	458
2024	16	217	15	572
2025	17	134	0	1,307
2026	9	140	1	—

What is it indicated for?

The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

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/K963855 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963855: 12 Ureteroscopes/Uretero-Renoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963855

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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