510(k) · Cleared

Cleared

HSW Resection Instruments

K173070510(k) TraditionalCleared Jun 8, 2018252-day reviewClass II21 CFR 884.1690

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

Henke-Sass, Wolf GmbH · HIH Hysteroscope (And Accessories)

Cleared on Jun 8, 2018 as substantially equivalent to K040390 (Stryker Endoscopy, 2004) after a 252-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Jun 8, 2018
Review: 252 days
Class: Class II
Product code: HIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040390 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK040390 Stryker Urology and Gynecology Hardware SystemStryker Endoscopy · 2004
This deviceK173070 HSW Resection InstrumentsHenke-Sass, Wolf GmbH · 2018
Descendant · cites it directly · 0 of its ownK243382 RZ Resectoscope SystemRz Medizintechnik GmbH · 2025

Most influential descendants

Showing 1 of 1 · See all

K243382RZ Resectoscope SystemRz Medizintechnik GmbH · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040390	Stryker Urology and Gynecology Hardware System	Stryker Endoscopy	2004	—
0 (this device)	K173070	HSW Resection Instruments	Henke-Sass, Wolf GmbH	2018	—
+1	K243382	RZ Resectoscope System	Rz Medizintechnik GmbH	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K173070, 2004–2025Source: 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 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

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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
*	K040390	Stryker Urology and Gynecology Hardware System Summary page 4 …HSW Resection Instruments 3. Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K040390 Applicant: Stryker Endoscopy Device Name: Stryker Urology and Gynecology Hardware System Regulat…	Stryker Endoscopy	2004	—

Also cleared against K040390: 6 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
K243382	RZ Resectoscope System	Rz Medizintechnik GmbH	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, K243382 (Rz Medizintechnik GmbH, 2025) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K040390.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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?

Read the full statement (131 words)

The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:

. Dilation of the urethra, and cold-slitting of urethral strictures

. Trans-urethral incision and resection of the prostate

. Trans-urethral removal of bladder tumor

. Trans-cervical resection and ablation of the endometrium

. Trans-cervical resection of fibroids

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173070: HSW Resection Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173070

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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