510(k) Report

510(k) · Cleared

Cleared

Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo

K251652510(k) TraditionalCleared Aug 1, 202564-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

American Medical Endoscopy, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid

Cleared on Aug 1, 2025 as substantially equivalent to K150158 (Schoelly Fiberoptic GmbH, 2015) after a 64-day review. Its family tree reaches back 5 generations to 1977. 1 later device descends from it.

Decided
Aug 1, 2025
Review
64 days
Class
Class II
Product code
FAJ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K770378 (1977). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1999: 4 other ancestors1996: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestor2026: 1 descendant clearedK770378 · Laparoscope, Fiber Light, Palmer-Jacobs · Richard Wolf Medical Instruments Corp. · 1977K962256 · Galileo Hysteroscopes and Laparoscopes · Galileo Electro-Optics Corp. · 1996K031974 · Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 · Asap Endoscopic Products GmbH · 2003K060899 · Flexilux II Cystoscope and Hysteroscope · Schoelly Imaging, Inc. · 2007K150158 · Schoelly Cystoscopes/Hysteroscopes and Accessories · Schoelly Fiberoptic GmbH · 2015 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors 1 generation forward: 1 descendant K150158 · Schoelly Cystoscopes/Hysteroscopes and Accessories · Schoelly Fiberoptic GmbH · 2015 · recalledK060899 · Flexilux II Cystoscope and Hysteroscope · Schoelly Imaging, Inc. · 2007K031974 · Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 · Asap Endoscopic Products GmbH · 2003K962256 · Galileo Hysteroscopes and Laparoscopes · Galileo Electro-Optics Corp. · 1996K770378 · Laparoscope, Fiber Light, Palmer-Jacobs · Richard Wolf Medical Instruments Corp. · 1977−50
  1. Root · 5 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
  2. 4 generations backK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
  3. 3 generations backK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
  4. 2 generations backK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
  5. 1 generation backK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
  6. This deviceK251652 Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA…American Medical Endoscopy, Inc. · 2025
  7. Descendant · cites it directly · 0 of its ownK253892 Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA…Strauss Surgical USA · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…Strauss Surgical USA · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K770378Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp.1977—
−4K962256Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp.1996—
−3K031974Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH2003—
−2K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc.2007—
−1K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH20151
0 (this device)K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope…American Medical Endoscopy, Inc.2025—
+1K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4…Strauss Surgical USA2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
199610
199940
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K251652, 1977–2026Source: 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
*K150158Schoelly Cystoscopes/Hysteroscopes and Accessories
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 K150158 Schoelly Cystoscopes/Hysteroscopes and accessories FAJ | Device Description Summary 21 CFR 807.92(a)(4) K251652,…
Schoelly Fiberoptic GmbH20151

Also cleared against K150158: 4 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
K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…Strauss Surgical USA20260

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 48 years and passes through 6 companies; a new generation was cleared every 8.0 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K253892 (Strauss Surgical USA, 2026) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K150158.

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. 2025, 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?

Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

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 K150158

4 other devices cite the same predicate.

  • K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2020
  • K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30…Solace Therapeutics, Inc. · 2017
  • K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
  • K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016

More from American Medical Endoscopy, Inc.

3 FDA decisions under this applicant name. See the company

  • K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc. · 2026
  • K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026

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/K251652 · printed Nov 4, 2026

Cite this page

510(k) Report. “K251652: Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251652

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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