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Aspiration Catheter 2189

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241874

by Hobbs Medical, Inc.

Identifiers

510(k) Number
K241874 FDA 510(k)
FDA Product Code
OCX 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 Aspiration Catheter 2189 is an endoscopic irrigation and suction system designed for the collection of fluids through a flexible endoscope. It features clear sheathing to facilitate visualization during diagnostic procedures and enables the efficient extraction of fluids from a target area.

This device is manufactured by Hobbs Medical, Inc. and has received FDA 510(k) clearance. It is intended for use within gastroenterology and urology clinical settings.

Frequently asked questions

What is the primary clinical use of the Aspiration Catheter 2189?

This device is designed for use in gastroenterology and urology clinical settings as an endoscopic irrigation and suction system to facilitate the collection of fluids from a target area.

How does the design of the catheter assist during diagnostic procedures?

The catheter features clear sheathing, which is intended to facilitate visualization for the clinician while they perform irrigation and suction tasks during diagnostic procedures.

What is the regulatory status of the Aspiration Catheter 2189?

The Aspiration Catheter 2189 has received FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: Aspiration Catheters - Hobbs Medical, Aspiration Catheter (2189) (K241874) | Medical Device Navigator, K241874 - Aspiration Catheter (2189) - FDA 510 (k), Aspiration Catheter (2189) (K241874) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hobbs Medical, Inc.

Sources (1)

  • FDA 510(k) K241874 24 fields · synced Sep 22, 2026