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FDA 510(k)

Mini PCNL-System

K-Number: K200770 · 2021-07-30

ApplicantTrokamed GmbH
Decision Date2021-07-30
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mini PCNL-System is a medical device manufactured by Trokamed GmbH. It received FDA 510(k) clearance on 2021-07-30 under approval number K200770. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mini PCNL-System?

Mini PCNL-System is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Trokamed GmbH. The 510(k) number is K200770.

When was Mini PCNL-System approved by the FDA?

Mini PCNL-System received FDA 510(k) clearance on 2021-07-30, under approval number K200770.

What company makes Mini PCNL-System?

Mini PCNL-System is manufactured by Trokamed GmbH.

What is the FDA product code for Mini PCNL-System?

The FDA product code for Mini PCNL-System is FED.

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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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