Cleared Special

PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

K030854 · E-Z-Em, Inc. · Gastroenterology & Urology
Apr 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K030854 is an FDA 510(k) clearance for the PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on April 16, 2003, 29 days after receiving the submission on March 18, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K030854 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2003
Decision Date April 16, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCX — Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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