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Vacutore Air/Water Bottle Tubing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191366

by Smartdata Suzhou Co., Ltd.

Identifiers

510(k) Number
K191366 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 Vacutore Air/Water Bottle Tubing is an Endoscopic Irrigation/Suction System used in gastroenterology and urology procedures. It is designed to facilitate the delivery of irrigation fluid and suction of fluids and debris during endoscopic interventions.

The device is supplied sterile and intended for single-use. It has a three-year shelf life and is packaged in a paper/film pouch. The device received FDA 510(k) clearance (K191366) on September 6, 2019, and is classified as a Class II medical device under regulation number 876.1500.

Frequently asked questions

What is the Vacutore Air/Water Bottle Tubing used for?

The Vacutore Air/Water Bottle Tubing is used to facilitate the delivery of irrigation fluid and suction of fluids and debris during endoscopic interventions in gastroenterology and urology procedures, enabling clear visualization and efficient debris removal.

How is the Vacutore Air/Water Bottle Tubing supplied and is it reusable?

The device is supplied sterile in a paper/film pouch and is intended for single-use only; it must not be reprocessed or reused due to the risk of contamination and loss of performance integrity after one use.

What is the shelf life and storage requirement for the Vacutore Air/Water Bottle Tubing?

The device has a three-year shelf life from the date of manufacture and should be stored in its original packaging under normal conditions to maintain sterility and functionality until use.

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: Vacutore Air/Water Bottle Tubing (K191366) — FDA 510 (k) | Innolitics, PDF Anna Reifschneider Responsible Third-Party Official Accelerated Device ..., K191366 FDA 510 (k) - Vacutore Air/Water Bottle Tubing, PDF K191366 - Vacutore Air/Water Bottle Tubing

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Smartdata Suzhou Co., Ltd.

Sources (1)

  • FDA 510(k) K191366 24 fields · synced Sep 21, 2026