Cleared Special

Erbe?s CO2 Tubing/Cap Sets

K162152 · Erbe USA, Inc. · Gastroenterology & Urology
Aug 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K162152 is an FDA 510(k) clearance for the Erbe?s CO2 Tubing/Cap Sets, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on August 31, 2016, 29 days after receiving the submission on August 2, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K162152 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2016
Decision Date August 31, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FEQ — Pump, Air, Non-manual, For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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