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FDA 510(k)

ENDOFLOW II - Irrigation, Warming and Suction System

K-Number: K152278 · 2016-02-09

ApplicantPromepla Sam
Decision Date2016-02-09
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOFLOW II - Irrigation, Warming and Suction System is a medical device manufactured by Promepla Sam. It received FDA 510(k) clearance on 2016-02-09 under approval number K152278. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFLOW II - Irrigation, Warming and Suction System?

ENDOFLOW II - Irrigation, Warming and Suction System is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by Promepla Sam. The 510(k) number is K152278.

When was ENDOFLOW II - Irrigation, Warming and Suction System approved by the FDA?

ENDOFLOW II - Irrigation, Warming and Suction System received FDA 510(k) clearance on 2016-02-09, under approval number K152278.

What company makes ENDOFLOW II - Irrigation, Warming and Suction System?

ENDOFLOW II - Irrigation, Warming and Suction System is manufactured by Promepla Sam.

What is the FDA product code for ENDOFLOW II - Irrigation, Warming and Suction System?

The FDA product code for ENDOFLOW II - Irrigation, Warming and Suction System is OCX.

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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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