Cleared Traditional

K924135 - FLEXIBLE URETERONEPHROSOCOPE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924135 · Applied Medical Resources · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
239d
Days
Class 2
Risk

K924135 is an FDA 510(k) clearance for the FLEXIBLE URETERONEPHROSOCOPE. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on April 14, 1993 after a review of 239 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Resources devices

Submission Details

510(k) Number K924135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date April 14, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 128d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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 General Hospital devices follow this clearance model.

Regulatory Peers - FEB Accessories, Cleaning, For Endoscope

All 56
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K924135.
System 83 Revolve Endoscope Washer/Disinfector
K241168 · Wassenburg Medical, Inc. · Dec 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · STERIS Corporation · Dec 2024
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · STERIS Corporation · Jun 2023
SCOPE BUDDY PLUS Endoscope Flushing Aid
K213833 · Medivators, Inc. · Jan 2022
Endoscope Reprocessor OER-Elite
K201920 · Olympus Medical Systems Corp. · Sep 2020