Cleared Traditional

K960677 - KANGAROO JEJUNAL FEEDING SYSTEM
(FDA 510(k) Clearance)

K960677 · Sherwood Medical Co. · Gastroenterology & Urology
May 1996
Decision
87d
Days
Class 2
Risk

K960677 is an FDA 510(k) clearance for the KANGAROO JEJUNAL FEEDING SYSTEM, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on May 13, 1996, 87 days after receiving the submission on February 16, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K960677 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1996
Decision Date May 13, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

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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