AN-10S Andersen Tube with Stylet
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K935688 FDA 510(k)
- FDA Product Code
- BSS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AN-10S Andersen Tube with Stylet is a nasogastric tube designed for gastric decompression and drainage. It features a dual-lumen (vented) design to maintain continuous and complete stomach emptying, reducing the risk of aspiration or gastric distension. Constructed for clinical use in gastroenterology and urology procedures, it is intended for insertion through the nose into the stomach.
This device is supplied sterile in a box of ten (BX 10) and is classified as a Class II medical device under FDA regulation 876.5980. It is intended for single-use and must be disposed of after use. The 16 French (Fr) size is standard for adult patients, and it is regulated under the FDA’s 510(k) clearance (K935688), with a decision of Substantially Equivalent (SESE) granted in 1994. No MRI safety information is specified.
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: AN-10S ANDERSEN TUBE WITH STYLET (K935688) - Innolitics, AN-10S ANDERSEN TUBE WITH STYLET 510 (k) K935688 - FDA.report, An10s Tube Nasogastric 16fr W/ Stylet Sterile ( Bx 10 ), Anderson Products An10s - Tube, Ng Anderson 16Fr W/stylet - 10/Box ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K935688 | Class II | Active |
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Manufacturer
- Manufacturer
- H.W. Andersen Products, Inc.
Sources (1)
- FDA 510(k) K935688 24 fields · synced Sep 19, 2026