Cleared Traditional

COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (K924655) - FDA 510(k) Clearance

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

K924655 · Cox Medical Ent., Inc. · General Hospital
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Dec 1992
Decision
91d
Days
Class 2
Risk

K924655 is an FDA 510(k) clearance for the COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2). Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Cox Medical Ent., Inc. (Ventura, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 91 days - within the typical 510(k) review window.

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 Cox Medical Ent., Inc. devices

Submission Details

510(k) Number K924655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1992
Decision Date December 15, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 10
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K924655.
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · Advanced Sterilization Products (Asp) · Apr 2019
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · United States Surgical, A Division of Tyco Healthc · Sep 1994