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Andersen Nasogastric Tube With Stylet (An 11s +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021493

by Andersen Products, Inc.

Identifiers

510(k) Number
K021493 FDA 510(k)
FDA Product Code
KNT FDA 510(k)
Models / Variants
An 11s FDA 510(k)
13s FDA 510(k)
14s FDA 510(k)
18s 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)

Andersen Nasogastric Tube With Stylet (An 11s +3 more) by Andersen Products, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K021493 24 fields · synced Jun 18, 2026