Gastrointestinal Cytology Brush

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

510(k) Number

K860997 ↗

FDA Product Code

FDX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Oval Cup Biopsy Forcep

  Class II

  FDA 510(k) K911155 Active Cleared 7 Aug 1991

• Cleaning Brush

  Class I

  FDA 510(k) K874239 Active Cleared 29 Dec 1987

• Guide Wire

  Class I

  FDA 510(k) K874164 Active Cleared 7 Dec 1987

• Sheath, Endoscope

  Class II

  FDA 510(k) K862059 Active Cleared 4 Nov 1986

• Polypectomy Snare

  Class II

  FDA 510(k) K862060 Active Cleared 27 Jun 1986

• Endoscopic Retrograde Cholangiopancreatography

  Class II

  FDA 510(k) K860990 Active Cleared 13 May 1986

See all devices from Endovations →

• What is the Endovations Gastrointestinal Cytology Brush used for?

  The Endovations Gastrointestinal Cytology Brush is designed for collecting cellular samples from the gastrointestinal tract during endoscopic procedures. It helps clinicians obtain tissue specimens for cytological examination, which is essential for identifying abnormalities such as dysplasia or malignancy. The structured bristle configuration ensures efficient sampling while minimizing patient discomfort.

• Is the Endovations Gastrointestinal Cytology Brush single-use or reusable?

  The Endovations Gastrointestinal Cytology Brush is supplied as a single-use, disposable instrument. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings where infection control is paramount.

• How should the Endovations Gastrointestinal Cytology Brush be stored?

  The brush should be stored in a clean, dry environment prior to use. Proper storage conditions help maintain its integrity and ensure it remains ready for sterile clinical use. Avoid exposure to moisture or extreme temperatures, as these can compromise the device’s performance and sterility.

• Is the Endovations Gastrointestinal Cytology Brush compatible with standard endoscopic equipment?

  Yes, the Endovations Gastrointestinal Cytology Brush is designed to be compatible with standard endoscopic equipment. This compatibility ensures seamless integration into existing clinical workflows, allowing clinicians to use it effectively during endoscopic procedures without additional modifications.

• What regulatory clearance does the Endovations Gastrointestinal Cytology Brush hold?

  The Endovations Gastrointestinal Cytology Brush is regulated under FDA 510(k) clearance with the clearance number K860997. It is classified as a Class II medical device under regulation number 876.1500, indicating it has undergone evaluation to ensure its safety and effectiveness for its intended use.