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AN3200 Doubilet Drain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872458

by H.W. Andersen Products, Inc.

Identifiers

510(k) Number
K872458 FDA 510(k)
FDA Product Code
FGE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5010 FDA 510(k)
Regulation Number
876.5010 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AN3200 Doubilet Drain is a stent, drain, or dilator for the biliary ducts designed for use as a temporary vent following a common duct exploration. The drainage portion of the tube features a latex film coating intended to encourage the formation of a fistulous tract from the cholecystectomy to the skin surface.

This device is supplied in a 9Fr size with a length of 45cm and is packaged in quantities of 10 per box. It is authorized under FDA 510(k) clearance K872458.

Frequently asked questions

What is the primary clinical purpose of the AN3200 Doubilet Drain?

This device is intended to function as a temporary stent, drain, or dilator for the biliary ducts. It is specifically designed to provide a temporary vent following a common duct exploration procedure.

How does the design of the drain assist in healing?

The drainage portion of the tube is coated with a latex film. This specific material is intended to encourage the formation of a fistulous tract from the cholecystectomy site to the skin surface.

What are the physical dimensions and packaging specifications for this device?

The AN3200 Doubilet Drain is supplied in a 9Fr size with a total length of 45cm. The product is packaged and sold in quantities of 10 units per box.

What is the regulatory status of the AN3200 Doubilet Drain?

This device is authorized under FDA 510(k) clearance K872458. It is classified under regulation number 876.5010 for stents, drains, and dilators for the biliary ducts.

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: AN3200 DOUBILET DRAIN 510 (k) K872458 - FDA.report, Andersen Products Inc,Wound drainage set 0.45 m | AN3200 Andersen Products, ANDERSEN PRODUCTS, INC. FDA Filings - FDA.report, Andersen Sterilizers, Inc. FDA 510 (k) Products 2022, AN3200 DOUBILET DRAIN 510 (k) K872458 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
H.W. Andersen Products, Inc.

Sources (1)

  • FDA 510(k) K872458 24 fields · synced Sep 22, 2026