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Endoscopy Irrigation Tubing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230773

by Zhejiang Chuangxiang Medical Technology Co., Ltd.

Identifiers

510(k) Number
K230773 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)

This device is an Endoscopic Irrigation/Suction System Tubing, designed to facilitate irrigation during gastrointestinal endoscopic procedures. It provides a sterile fluid pathway for rinsing and cleaning the endoscope’s working channel, ensuring visibility and maintaining procedural hygiene during use.

The tubing is intended for single-use and is supplied sterile, compatible with various gastrointestinal endoscopes and irrigation pumps. It is classified as Class II under FDA regulation 876.1500, with an FDA 510(k) clearance (K230773) for use in gastroenterology and urology settings. Multiple registration numbers (e.g., 3011193403) reflect its distribution across global markets.

Frequently asked questions

What procedures is this irrigation tubing designed to support during endoscopy?

This tubing is specifically designed to facilitate irrigation during gastrointestinal endoscopic procedures, ensuring the working channel of the endoscope remains clear for optimal visibility. It is compatible with irrigation pumps and supports procedural hygiene by providing a sterile fluid pathway for rinsing. While the FDA clearance includes gastroenterology and urology settings, the tubing itself is not procedure-specific but rather a supportive accessory for maintaining endoscope functionality during these types of examinations.

Is this tubing reusable or intended for single-use, and how is it supplied?

The tubing is explicitly designed for single-use only, as stated in the product description. It is supplied sterile, ensuring immediate readiness for clinical use without the need for reprocessing. Each unit is packaged to maintain sterility until first use, which is critical for infection control during endoscopic procedures.

What types of endoscopes or irrigation systems can this tubing be used with?

This tubing is compatible with various gastrointestinal endoscopes and irrigation pumps commonly used in clinical settings. While the exact models aren’t listed, its design aligns with standard endoscopic irrigation systems, ensuring compatibility with most procedures requiring fluid exchange through the working channel. Always verify compatibility with your specific endoscope model before use.

How should this tubing be stored to maintain its integrity and sterility?

Since the tubing is supplied sterile and intended for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain sealed until immediately before use to preserve sterility. Avoid exposure to moisture, chemicals, or physical damage that could compromise the tubing’s integrity or sterility.

What regulatory pathway was followed for this device’s clearance, and how does that affect its use?

This tubing received FDA 510(k) clearance (K230773) under the Traditional pathway, demonstrating it is substantially equivalent to a predicate device. The clearance was granted by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its intended use in those specialties. Clinically, this means it meets FDA standards for safety and effectiveness in its designated applications, though the actual use remains within the scope of standard endoscopic practices—never implying it replaces or alters procedural indications.

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: Endoscopy Irrigation Tubing by Zhejiang Chuangxiang Medical Technology ..., PDF November 21, 2023 Zhejiang Chuangxiang Medical Technology Co., LTD ..., K230773 FDA 510(k) - Endoscopy Irrigation Tubing, Zhejiang Chuangxiang Medical Technology Co., LTD. MD-A-IT-3000 ... - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zhejiang Chuangxiang Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K230773 24 fields · synced Sep 19, 2026