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FDA 510(k)

rTOP

K-Number: K243333 · 2025-02-04

ApplicantRoclub GmbH
Decision Date2025-02-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

rTOP is a medical device manufactured by Roclub GmbH. It received FDA 510(k) clearance on 2025-02-04 under approval number K243333. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the rTOP?

rTOP is a medical device that received FDA 510(k) clearance on 2025-02-04. It is manufactured by Roclub GmbH. The 510(k) number is K243333.

When was rTOP approved by the FDA?

rTOP received FDA 510(k) clearance on 2025-02-04, under approval number K243333.

What company makes rTOP?

rTOP is manufactured by Roclub GmbH.

What is the FDA product code for rTOP?

The FDA product code for rTOP is LLZ.

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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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