Cleared Traditional

CFlex Cystoscope - Standard Deflection (0570-0455) (K253696) - FDA 510(k) Clearance

Also marketed or referenced as:
CFlex Cystoscope - Reverse Deflection (0570-0456) CystoView Monitor (0570-0465)

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

K253696 · Verathon Medical (Canada) Ulc · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
171d
Days
Class 2
Risk

K253696 is an FDA 510(k) clearance for the CFlex Cystoscope - Standard Deflection (0570-0455). Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Verathon Medical (Canada) Ulc (Burnaby, CA). The FDA issued a Cleared decision on May 11, 2026 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Verathon Medical (Canada) Ulc devices

Submission Details

510(k) Number K253696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date May 11, 2026
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
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 K253696.
OES ELITE Cystoscope and Accessories
K260649 · Olympus Winter & Ibe GmbH · May 2026
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