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Gastrointestinal Cytology Brush

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901435

by TeleMed Systems

Identifiers

510(k) Number
K901435 FDA 510(k)
FDA Product Code
FDX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gastrointestinal Cytology Brush is a diagnostic device classified as an Endoscopic Cytology Brush, designed for the collection of cellular samples from the gastrointestinal tract. It facilitates cytological examination by obtaining tissue specimens during endoscopic procedures, aiding in the detection and diagnosis of abnormalities such as dysplasia or malignancy.

This device is supplied as a single-use, non-sterile instrument and is intended for use in clinical settings such as gastroenterology and urology. It is regulated under FDA 510(k) clearance (K901435) and falls under the product code FDX, classified as a Class II medical device. Proper storage and handling are essential to maintain its integrity before use.

Frequently asked questions

What medical specialties primarily use this cytology brush during procedures, and why is it relevant to those fields?

This device is primarily used in gastroenterology and urology specialties. It is designed for collecting cellular samples from the gastrointestinal tract during endoscopic procedures, which helps detect abnormalities like dysplasia or malignancy. These specialties rely on accurate cytological examination to diagnose conditions such as esophageal, gastric, or bladder abnormalities, making this brush a critical tool in their diagnostic workflow.

Is this brush intended for single-use or reusable applications, and what does that mean for clinical workflows?

The Gastrointestinal Cytology Brush is supplied as a single-use, non-sterile instrument. This means each brush is intended for one procedure only, reducing the risk of cross-contamination between patients. Clinicians must open a new brush for each patient, ensuring proper handling and disposal after use to maintain hygiene and regulatory compliance.

How should this device be stored before use, and why is proper storage important?

While the device is non-sterile, proper storage is still critical to maintain its integrity before use. It should be kept in a clean, dry environment, protected from moisture, dust, and physical damage. Since it is single-use, storage conditions help preserve its functionality until the time of use, ensuring it remains effective for its intended diagnostic purpose during endoscopic procedures.

What regulatory pathway does this device follow, and how does that affect its availability or use?

This device follows the FDA 510(k) clearance pathway, with the specific clearance number K901435. It is classified as a Class II medical device under product code FDX, meaning it has undergone FDA review to demonstrate substantial equivalence to a predicate device. Clinicians and buyers can confirm its regulatory status through the FDA’s database using the provided clearance number, ensuring compliance with U.S. medical device regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gastrointestinal Cytology Brushes - Telemed Systems, Products - Telemed Systems, Disposable Gastrointestinal Cytology Brush — FDA Class II Medical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
TeleMed Systems
FDA Applicant
Telemed Systems, Inc.

Sources (1)

  • FDA 510(k) K901435 24 fields · synced Sep 19, 2026