Cleared Traditional

K945262 - OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (FDA 510(k) Clearance)

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

K945262 · Optus, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
210d
Days
Class 2
Risk

K945262 is an FDA 510(k) clearance for the OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Optus, Inc. (Denver, US). The FDA issued a Cleared decision on May 26, 1995 after a review of 210 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 Optus, Inc. devices

Submission Details

510(k) Number K945262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date May 26, 1995
Days to Decision 210 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
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 89
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K945262.
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