Cleared Traditional

REPLACEMENT GASTROSTOMY TUBE

K861323 · Microvasive · Gastroenterology & Urology
Dec 1986
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K861323 is an FDA 510(k) clearance for the REPLACEMENT GASTROSTOMY TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on December 16, 1986, 252 days after receiving the submission on April 8, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K861323 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1986
Decision Date December 16, 1986
Days to Decision 252 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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