510(k) Report

510(k) · Cleared

Cleared

OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,

K260649510(k) TraditionalCleared May 21, 202683-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

Olympus Winter & Ibe GmbH · FAJ Cystoscope And Accessories, Flexible/Rigid

Cleared on May 21, 2026 as substantially equivalent to K011496 (Richard Wolf Medical Instruments Corp., 2001) after an 83-day review. Its family tree reaches back 3 generations to 1990.

Decided
May 21, 2026
Review
83 days
Class
Class II
Product code
FAJ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K895857 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK895857 · Continuous Irrigation Resectoscope Syst/Gynecology · Richard Wolf Medical Instruments Corp. · 1990K980302 · Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes · Richard Wolf Medical Instruments Corp. · 1998 · recalledK011496 · Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 · Richard Wolf Medical Instruments Corp. · 20011990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor K011496 · Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 · Richard Wolf Medical Instruments Corp. · 2001K980302 · Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes · Richard Wolf Medical Instruments Corp. · 1998 · recalledK895857 · Continuous Irrigation Resectoscope Syst/Gynecology · Richard Wolf Medical Instruments Corp. · 19900
  1. Root · 3 generations backK895857 Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp. · 1990
  2. 2 generations backK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998 · Recalled
  3. 1 generation backK011496 Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators…Richard Wolf Medical Instruments Corp. · 2001
  4. This deviceK260649 OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO)…Olympus Winter & Ibe GmbH · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K895857Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp.1990—
−2K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp.19981
−1K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts…Richard Wolf Medical Instruments Corp.2001—
0 (this device)K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator…Olympus Winter & Ibe GmbH2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K260649, 1990–2026Source: 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
*K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…
Summary page 7
…e and Accessories, Flexible/Rigid) Regulatory class: II Submission type: Traditional 510(k) Submission III. PREDICATE DEVICE 510k number: K011496 Product name: Cysto-Urethroscope 8650 E-line Applicant: Richard Wolf GmbH…
Richard Wolf Medical Instruments Corp.2001—

Also cleared against K011496: 1 other device →

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 36 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K011496.

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. 2026, 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?

The cystoscopes and accessories are intended for endoscopic diagnosis and therapy in the lower urinary tract. Together with compatible instruments endoscopic diagnostic and therapeutic procedures can be performed. Access is gained through a minimally invasive approach by utilizing natural orifices.

The product is intended to be used for patients from 18 years of age and up.

Indications for use as stated in the FDA summary.

Also cleared against K011496

1 other device cites the same predicate.

  • K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both…Daniel & Daniel Consulting · 2014

More from Olympus Winter & Ibe GmbH

43 FDA decisions under this applicant name. See the company

  • K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar…Olympus Winter & Ibe GmbH · 2025
  • K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches…Olympus Winter & Ibe GmbH · 20232 recalls
  • K221522HF-cables (resusable)Olympus Winter & Ibe GmbH · 2023
  • K223183Light-Guide CablesOlympus Winter & Ibe GmbH · 2023
  • K213207Sheath, Stopcock AccessoryOlympus Winter & Ibe GmbH · 2021

Recent decisions in FAJ

The FAJ category page

  • 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
  • K253226UV5000W HandleUroviu Corporation · 2025

https://510kreport.com/device/K260649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260649: OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260649

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026