Cleared Traditional

FOOTPRINT MEDICAL SILICONE FEEDING TUBE

K090559 · Footprint Medical · Gastroenterology & Urology
May 2009
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K090559 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL SILICONE FEEDING TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on May 4, 2009, 63 days after receiving the submission on March 2, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K090559 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2009
Decision Date May 04, 2009
Days to Decision 63 days
Submission Type Traditional
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

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