Cleared Traditional

K901426 - COLONIC BALLOON DILATOR
(FDA 510(k) Clearance)

K901426 · Telemed Systems, Inc. · Gastroenterology & Urology
Jun 1990
Decision
87d
Days
Class 1
Risk

K901426 is an FDA 510(k) clearance for the COLONIC BALLOON DILATOR, a Dilator, Rectal (Class I — General Controls, product code FFP), submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 21, 1990, 87 days after receiving the submission on March 26, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5450.

Submission Details

510(k) Number K901426 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1990
Decision Date June 21, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FFP — Dilator, Rectal
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5450