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FDA 510(k)

SmartStart Air/Water and Suction Valves

K-Number: K160403 · 2016-05-19

ApplicantEndochoice, Inc.
Decision Date2016-05-19
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartStart Air/Water and Suction Valves is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-19 under approval number K160403. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartStart Air/Water and Suction Valves?

SmartStart Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Endochoice, Inc.. The 510(k) number is K160403.

When was SmartStart Air/Water and Suction Valves approved by the FDA?

SmartStart Air/Water and Suction Valves received FDA 510(k) clearance on 2016-05-19, under approval number K160403.

What company makes SmartStart Air/Water and Suction Valves?

SmartStart Air/Water and Suction Valves is manufactured by Endochoice, Inc..

What is the FDA product code for SmartStart Air/Water and Suction Valves?

The FDA product code for SmartStart Air/Water and Suction Valves is ODC.

Other Devices by Endochoice, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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