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FDA 510(k)

Disposable Monopolar Laparoscopic Tips and Reusable Handles

K-Number: K211019 · 2021-10-28

ApplicantDannik, LLC
Decision Date2021-10-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Monopolar Laparoscopic Tips and Reusable Handles is a medical device manufactured by Dannik, LLC. It received FDA 510(k) clearance on 2021-10-28 under approval number K211019. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Monopolar Laparoscopic Tips and Reusable Handles?

Disposable Monopolar Laparoscopic Tips and Reusable Handles is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Dannik, LLC. The 510(k) number is K211019.

When was Disposable Monopolar Laparoscopic Tips and Reusable Handles approved by the FDA?

Disposable Monopolar Laparoscopic Tips and Reusable Handles received FDA 510(k) clearance on 2021-10-28, under approval number K211019.

What company makes Disposable Monopolar Laparoscopic Tips and Reusable Handles?

Disposable Monopolar Laparoscopic Tips and Reusable Handles is manufactured by Dannik, LLC.

What is the FDA product code for Disposable Monopolar Laparoscopic Tips and Reusable Handles?

The FDA product code for Disposable Monopolar Laparoscopic Tips and Reusable Handles is GEI.

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Other Devices by Dannik, LLC

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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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