Cleared Traditional

K260649 - OES ELITE Cystoscope and Accessories (FDA 510(k) Clearance)

Also includes:
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,

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260649 · Olympus Winter & Ibe GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
83d
Days
Class 2
Risk

K260649 is an FDA 510(k) clearance for the OES ELITE Cystoscope and Accessories. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on May 21, 2026 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K260649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2026
Decision Date May 21, 2026
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAJ Cystoscope And Accessories, Flexible/rigid

All 91
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K260649.
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable)
K253892 · Strauss Surgical USA · Apr 2026
PrimeSight UltraView System
K253905 · Cogentix Medical, Inc. · Apr 2026
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
K260271 · American Medical Endoscopy, Inc. · Mar 2026
UV5000W Handle
K253226 · Uroviu Corporation · Oct 2025
Zenflow Spring Scope
K251140 · Zenflow, Inc. · Sep 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K252598 · Shanghai AnQing Medical Instrument Co., Ltd. · Sep 2025