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FDA 510(k)

Dannik Laparoscopic Suction Irrigation System

K-Number: K192643 · 2019-11-19

ApplicantDannik
Decision Date2019-11-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dannik Laparoscopic Suction Irrigation System is a medical device manufactured by Dannik. It received FDA 510(k) clearance on 2019-11-19 under approval number K192643. 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 Dannik Laparoscopic Suction Irrigation System?

Dannik Laparoscopic Suction Irrigation System is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Dannik. The 510(k) number is K192643.

When was Dannik Laparoscopic Suction Irrigation System approved by the FDA?

Dannik Laparoscopic Suction Irrigation System received FDA 510(k) clearance on 2019-11-19, under approval number K192643.

What company makes Dannik Laparoscopic Suction Irrigation System?

Dannik Laparoscopic Suction Irrigation System is manufactured by Dannik.

What is the FDA product code for Dannik Laparoscopic Suction Irrigation System?

The FDA product code for Dannik Laparoscopic Suction Irrigation System is GCJ.

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Other Devices by Dannik

K192711Dannik Titanium Ligation Clip K201063DANNIK Disposable Monopolar Laparoscopic Instrument K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) K193019DANNIK Disposable Monopolar Laparoscopic Instrument

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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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