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Dannik Laparoscopic Suction Irrigation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192643

by Dannik

Identifiers

510(k) Number
K192643 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dannik Laparoscopic Suction Irrigation System is a laparoscopic surgical instrument used for suction and irrigation during surgical procedures. It is designed to deliver sterile irrigation fluids to surgical sites. The system is indicated for use in patients undergoing laparoscopic surgical procedures.

The system is supplied for use in minimally invasive surgery and is intended for use in a clinical setting. It has been granted FDA 510K authorization. The system is designed for use in laparoscopic procedures, including general and plastic surgery. It is available with a product code of GCJ and k number K192643.

Frequently asked questions

What is the Dannik Laparoscopic Suction Irrigation System used for?

The Dannik Laparoscopic Suction Irrigation System is used for suction and irrigation during laparoscopic surgical procedures, delivering sterile irrigation fluids to surgical sites.

Is the Dannik Laparoscopic Suction Irrigation System intended for single-use or reuse?

The description does not explicitly state whether the system is for single-use or reuse, but it is designed for use in a clinical setting, suggesting it may be reusable with proper sterilization.

What type of surgeries is the Dannik Laparoscopic Suction Irrigation System indicated for?

The system is indicated for use in patients undergoing laparoscopic surgical procedures, including general and plastic surgery.

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

The product code for the Dannik Laparoscopic Suction Irrigation System is GCJ, with a k number of K192643.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products — Dannik, [PDF] November 19, 2019 DANNIK Olga Haberland Regulatory ..., 510(k) Premarket Notification - FDA, Dannik Laparoscopic Suction Irrigation System by Dannik | FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dannik

Sources (1)

  • FDA 510(k) K192643 24 fields · synced Sep 28, 2026