Cleared Special

K043027 - MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 (FDA 510(k) Clearance)

K043027 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
Dec 2004
Decision
29d
Days
Class 2
Risk

K043027 is an FDA 510(k) clearance for the MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 2, 2004, 29 days after receiving the submission on November 3, 2004.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K043027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 03, 2004
Decision Date December 02, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980