Cleared Traditional

UNI-TIP COLOSTOMY IRRIGATION CONE

K823274 · Howmedica Corp. · Gastroenterology & Urology
Dec 1982
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K823274 is an FDA 510(k) clearance for the UNI-TIP COLOSTOMY IRRIGATION CONE, a Irrigator, Ostomy (Class II — Special Controls, product code EXD), submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1982, 34 days after receiving the submission on November 3, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5895.

Submission Details

510(k) Number K823274 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1982
Decision Date December 07, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EXD — Irrigator, Ostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5895