510(k) Report

510(k) · Cleared

Cleared

Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

K171336510(k) TraditionalCleared Dec 7, 2017213-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

Henke-Sass, Wolf GmbH · FAJ Cystoscope And Accessories, Flexible/Rigid

Cleared on Dec 7, 2017 as substantially equivalent to K040390 (Stryker Endoscopy, 2004) after a 213-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided
Dec 7, 2017
Review
213 days
Class
Class II
Product code
FAJ
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.

Descendants, by year cleared 2026: 1 descendant clearedK040390 · Stryker Urology and Gynecology Hardware System · Stryker Endoscopy · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K040390 · Stryker Urology and Gynecology Hardware System · Stryker Endoscopy · 20040
  1. Root · 1 generation backK040390 Stryker Urology and Gynecology Hardware SystemStryker Endoscopy · 2004
  2. This deviceK171336 Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm…Henke-Sass, Wolf GmbH · 2017
  3. Descendant · cites it directly · 0 of its ownK260271 Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040390Stryker Urology and Gynecology Hardware SystemStryker Endoscopy2004—
0 (this device)K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0°…Henke-Sass, Wolf GmbH2017—
+1K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K171336, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FAJ? 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 FAJ device

  1. #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040390Stryker Urology and Gynecology Hardware System
Summary page 4
…Urethroscope Sheath 5.3 Predicate Device The legally marketed device to which substantial equivalence is being claimed is: 510(k) Number: K040390 Applicant: Stryker Endoscopy Device Name: Stryker Urology and Gynecology Hardware System Regulatio…
Stryker Endoscopy2004—

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.

NumberDeviceApplicantDecidedDescendants
K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.20260

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, K260271 (American Medical Endoscopy, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K040390.

How does its category compare?

All FAJ devices

FAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · FAJ

8in 2025

2007: 22009: 22010: 12012: 12014: 12016: 12017: 22018: 22019: 32020: 22021: 32022: 52023: 52024: 92025: 82026 (partial year): 5
2007high 9 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAJ

98in 2025

2019: 207 days median2021: 127 days median2022: 170 days median2023: 207 days median2024: 130 days median2025: 98 days median2026 (partial year): 123 days median
2007high 207 (2019) · low 98 (2025)2026

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

Recalls per year · FAJ

7in 2023

2017: 12022: 12023: 7
2007high 7 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FAJ

2,690in 2025

2007: 92008: 102009: 102010: 92011: 132012: 82013: 122014: 62015: 282016: 752017: 792018: 792019: 1022020: 3392021: 4942022: 7442023: 9202024: 8922025: 2,690
2007high 2,690 (2025) · low 6 (2014)2025

MAUDE reports naming product code FAJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—09
20080—010
20092—010
20101—09
20110—013
20121—08
20130—012
20141—06
20150—028
20161—075
20172—179
20182—079
201932070102
20202—0339
202131270494
202251701744
202352077920
202491300892
202589802,690
202651230—

What is it indicated for?

a. Endoscopes The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach…

Read the full statement (139 words)

a. Endoscopes

The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

b. Urology Instruments

The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

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

Also cleared against K040390

6 other devices cite the same predicate.

  • K252012SPY Cystoscope/HysteroscopeStryker Endoscopy · 2025
  • K233635SPY Cystoscope/HysteroscopeStryker Endoscopy · 2024
  • K173070HSW Resection InstrumentsHenke-Sass, Wolf GmbH · 2018
  • K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 20151 recall
  • K142194CytoSure Urinary Access SystemEmmy Medical · 2014
  • K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009

More from Henke-Sass, Wolf GmbH

6 FDA decisions under this applicant name. See the company

  • K173070HSW Resection InstrumentsHenke-Sass, Wolf GmbH · 2018
  • K101547Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010
  • K952186HSW GMBH Hysteroscopes & AccessoriesHenke-Sass, Wolf GmbH · 1996
  • K943624Elmed Pneumoperitoneum NeedlesHenke-Sass, Wolf GmbH · 1994
  • K941967HSW Laparoscope and AccessoriesHenke-Sass, Wolf GmbH · 1994

Recent decisions in FAJ

The FAJ category page

  • K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO)…Olympus Winter & Ibe GmbH · 2026
  • K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456)…Verathon Medical (Canada) Ulc · 2026
  • K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°…Strauss Surgical USA · 2026
  • K253905PrimeSight UltraView SystemCogentix Medical, Inc. · 2026
  • K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026

https://510kreport.com/device/K171336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171336: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171336

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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