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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 the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2019-11-19 under 510(k) 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. The listed applicant is Dannik. The 510(k) number is K192643.

When did Dannik Laparoscopic Suction Irrigation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Dannik Laparoscopic Suction Irrigation System?

The FDA 510(k) record lists Dannik as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Dannik as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemK211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesK210569Disposable Monopolar Laparoscopic Shafts and Reusable HandlesK201063DANNIK Disposable Monopolar Laparoscopic InstrumentK200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)K193019DANNIK Disposable Monopolar Laparoscopic Instrument

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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