510(k) · Cleared
ClearedStrauss Surgical cystoscope, hysteroscope and accessories Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Endoscopy, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Mar 27, 2026 as substantially equivalent to K171336 (Henke-Sass, Wolf GmbH, 2017) after a 58-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Mar 27, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040390 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backK040390 Stryker Urology and Gynecology Hardware SystemStryker Endoscopy · 2004
- 1 generation backK171336 Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm…Henke-Sass, Wolf GmbH · 2017
- This deviceK260271 Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040390 | Stryker Urology and Gynecology Hardware System | Stryker Endoscopy | 2004 | — |
| −1 | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0°… | Henke-Sass, Wolf GmbH | 2017 | — |
| 0 (this device) | K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | 2026 | — |
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 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm…Summary page 5…1500 Product Code(s) FAJ, HIH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K171336 Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope FAJ 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Br… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
Endoscopes: 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 Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access…
Read the full statement (130 words)
Endoscopes:
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 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.
Urology Instruments:
The 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.
https://510kreport.com/device/K260271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260271: Strauss Surgical cystoscope, hysteroscope and accessories Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260271
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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