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FDA 510(k)

Single Use Surgical Suction Irrigator

K-Number: K161421 · 2016-06-24

ApplicantJiangsu Haize Medical Scientific Development Co., Ltd.
Decision Date2016-06-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Surgical Suction Irrigator is a medical device manufactured by Jiangsu Haize Medical Scientific Development Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under approval number K161421. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Surgical Suction Irrigator?

Single Use Surgical Suction Irrigator is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Jiangsu Haize Medical Scientific Development Co., Ltd.. The 510(k) number is K161421.

When was Single Use Surgical Suction Irrigator approved by the FDA?

Single Use Surgical Suction Irrigator received FDA 510(k) clearance on 2016-06-24, under approval number K161421.

What company makes Single Use Surgical Suction Irrigator?

Single Use Surgical Suction Irrigator is manufactured by Jiangsu Haize Medical Scientific Development Co., Ltd..

What is the FDA product code for Single Use Surgical Suction Irrigator?

The FDA product code for Single Use Surgical Suction Irrigator is GCJ.

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Official Source

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

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