Cytology Brush (FDX)

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

Full name

Cytology Brush

510(k) Number

K913248 ↗

FDA Product Code

FDX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Metal Ureteral Basket Stone Dislodger

  Class II

  FDA 510(k) K951532 Active Cleared 19 Jul 1995

• Biopsy Forceps

  Class II

  FDA 510(k) K895098 Active Cleared 30 Oct 1989

• Flexible Snare

  Class II

  FDA 510(k) K902265 Active Cleared 27 Jul 1990

• Grasping Forceps or Retrieval Forceps

  Class II

  FDA 510(k) K934598 Active Cleared 7 Jan 1994

• Biliary Stone Dislodger LQR

  Class II

  FDA 510(k) K925559 Active Cleared 17 Dec 1992

• Forceps, Grasping, Flexible Endoscopic

  Class II

  FDA 510(k) K954377 Active Cleared 26 Oct 1995

See all devices from Annex Medical, Inc. →

• What are the primary clinical applications for the Cytology Brush, and which medical specialties commonly use it?

  The Cytology Brush is specifically designed for collecting cellular samples from mucosal surfaces during endoscopic procedures. It is primarily used in diagnostic cytology within gastroenterology and urology, where precise sampling of tissues in the airway, gastrointestinal, or urinary tracts is required for pathological examination. Clinicians in these specialties rely on it to obtain accurate samples for diagnosing conditions like dysplasia, infection, or malignancy.

• Is the Cytology Brush intended for single-use or reusable applications, and how is it supplied?

  The Cytology Brush is a single-use device, meaning it is not designed for reuse after a single procedure. It is supplied sterile, ensuring safety and reliability for immediate clinical use without additional preparation. This aligns with best practices for minimizing infection risk in endoscopic procedures.

• What regulatory pathway was followed for FDA clearance of the Cytology Brush, and what does this mean for its use?

  The Cytology Brush received FDA 510(k) clearance (K913248) under the traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the device was determined to have the same intended use and technological characteristics as a previously cleared product, ensuring it meets regulatory standards for safety and effectiveness in diagnostic cytology procedures.

• Which endoscopic procedures or anatomical regions is the Cytology Brush compatible with, and how does its design support precision sampling?

  The Cytology Brush is engineered for use in procedures involving the airway, gastrointestinal tract (e.g., esophagus, stomach, colon), or urinary tract, where mucosal surfaces require precise sampling. Its design allows clinicians to collect cellular samples accurately during endoscopy, facilitating detailed pathological analysis for conditions like Barrett’s esophagus, colorectal polyps, or bladder abnormalities.