510(k) · Cleared

Recalled · Class II · 2019

Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes

K980302510(k) TraditionalCleared Jul 20, 1998174-day reviewClass II21 CFR 884.1690Recalls 1

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. · HIH Hysteroscope (And Accessories)

Cleared on Jul 20, 1998 as substantially equivalent to K895857 (Richard Wolf Medical Instruments Corp., 1990) and 1 other predicate after a 174-day review. Its family tree reaches back 1 generation to 1990. 19 later devices descend from it. It has been recalled once.

Decided: Jul 20, 1998
Review: 174 days
Class: Class II
Product code: HIH
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K895857 (1990). 2 ancestors in all. 19 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK895857 Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp. · 1990
This deviceK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998
Descendant · cites it directly · 12 of its ownK011496 Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators…Richard Wolf Medical Instruments Corp. · 2001
Descendant · 2 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
Descendant · 3 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
Descendant · 4 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
Descendant · 3 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2001high 2 (2014) · low 0 (2002)2026

Most influential descendants

Showing 5 of 19 · See all

K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…Richard Wolf Medical Instruments Corp. · 2001 · cites it directly12descendants
K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 2 generations on10descendants
K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 3 generations on9descendants
K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 4 generations on7descendants
K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895857	Continuous Irrigation Resectoscope Syst/Gynecology	Richard Wolf Medical Instruments Corp.	1990	—
0 (this device)	K980302	Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes	Richard Wolf Medical Instruments Corp.	1998	—
+1	K011496	Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts…	Richard Wolf Medical Instruments Corp.	2001	—
+2	K132389	Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes…	Daniel & Daniel Consulting	2014	—
+3	K141358	Cellvizio 100 Series with System Confocal Miniprobes	Mauna Kea Technologies	2014	—
+4	K160416	CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal…	Mauna Kea Technologies	2016	—
+3	K150831	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	1	0
2006	1	0
2007	1	0
2010	1	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2019	2	0
2020	2	0
2021	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K980302, 1990–2026Source: 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 HIH? 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 HIH device

#1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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? (4)

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
*	K895857	Continuous Irrigation Resectoscope Syst/Gynecology Summary page 1 …o 8439 Common Name: Classification Name: Resectoscope Resectoscope, Resectoscope, Working Element o 510¢k) Number Trade or proprietary or model name Manufacturer 1 K895857/A 1 Continuous Irrigation Resectoscope \| I Richard Wolf System, Model 8655 2 K953983 2 EVAP Electrodes Model 8423, 2 Richard Wo…	Richard Wolf Medical Instruments Corp.	1990	—
*	K953983	Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue Summary page 1 …rking Element o 510¢k) Number Trade or proprietary or model name Manufacturer 1 K895857/A 1 Continuous Irrigation Resectoscope \| I Richard Wolf System, Model 8655 2 K953983 2 EVAP Electrodes Model 8423, 2 Richard Wolf 8427, 8410, 8413 3 3 USA Elite System Resectoscopes 3 Circon ACMI 4 4 Resectoscope…	Richard Wolf Medical Instruments Corp.	1996	—
*	—	USA Elite System Resectoscopes Named without a submission number			—
*	—	Resectoscopes 27040-27050, 27143 Named without a submission number			—

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K011496	Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…	Richard Wolf Medical Instruments Corp.	2001	12
K062720	S-Line Bipolar Resectoscopes and Bipolar Electrodes	Richard Wolf Medical Instruments Corp.	2007	2
K050910	Roei Working Element and Roel Cutting Loops	Roei Medical Technologies, Ltd.	2005	1
K102663	Aed Resectoscope	National Advanced Endoscopy Devices, Inc.	2010	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 23, 2019	Class II	Z-1957-2019	Under Investigation by firm	E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K011496 (Richard Wolf Medical Instruments Corp., 2001) has gone furthest, with 12 descendants of its own.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIH

3in 2025

2007high 14 (2019) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIH

111in 2025

2007high 200 (2023) · low 25 (2012)2026

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

Recalls per year · HIH

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · HIH

1,698in 2025

2007high 1,698 (2025) · low 7 (2007)2025

MAUDE reports naming product code HIH, 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	7
2008	2	—	0	12
2009	4	130	0	17
2010	4	109	0	31
2011	3	118	0	59
2012	4	25	0	78
2013	5	144	0	111
2014	2	—	0	125
2015	5	52	0	211
2016	3	106	0	172
2017	2	—	0	336
2018	8	135	0	182
2019	14	91	1	220
2020	7	88	0	253
2021	4	194	0	193
2022	2	—	0	289
2023	4	200	2	1,449
2024	6	148	0	1,611
2025	3	111	0	1,698
2026	7	168	3	—

What is it indicated for?

Intended Use.

Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology.

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/K980302 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980302

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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