Cox Disposable Endoscope Cleaning Brush

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914442 ↗

FDA Product Code

FEB

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Cox Disposable Cytology Brushes

  Class II

  FDA 510(k) K914466 Active Cleared 25 Oct 1991

• Modular Biopsy Forcep

  Class I

  FDA 510(k) K946360 Active Cleared 6 Mar 1995

• Cox Diaposable Polypectomy Snare

  Class II

  FDA 510(k) K912254 Active Cleared 26 Jul 1991

• Cox Disposable Endoscope Cleaning Brush(Cb-X2)

  Class II

  FDA 510(k) K924655 Active Cleared 15 Dec 1992

• Cox Disposable Polypectomy Snares

  Class II

  FDA 510(k) K923671 Active Cleared 13 Oct 1992

• Basics Endoscopy System

  Class II

  FDA 510(k) K940911 Active Cleared 16 May 1994

See all devices from Cox Medical Ent., Inc. →

• What clinical specialties is this brush intended to support during endoscope cleaning and maintenance?

  This brush is specifically designed for use in gastroenterology and urology procedures, where endoscopes require thorough cleaning to remove debris and biofilm during reprocessing. Its FDA classification under 876.1500 and advisory committee designation (GU) confirm its primary application in these specialties.

• Is this brush reusable, or is it meant for single-use only? How does that affect its use in clinical settings?

  The brush is explicitly labeled as disposable and single-use only, meaning it cannot be reused after one cleaning cycle. This design ensures hygiene and reduces cross-contamination risks in clinical settings like gastroenterology and urology, where endoscope reprocessing must adhere to strict infection control protocols.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use in the U.S.?

  The brush received FDA 510(k) clearance (K914442) under the Traditional pathway, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a cleaning accessory for endoscopes, allowing its legal use in U.S. clinical settings for its intended purpose.

• Are there any special storage requirements for this brush before use, or can it be stored alongside other endoscope accessories?

  The device data does not specify storage conditions, but as a disposable single-use item, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it’s not sterile (no sterility claims are made), it should not be stored in a sterile field or alongside sterile supplies. Always check the packaging for manufacturer-specific storage instructions.