rTOP
K-Number: K243333 · 2025-02-04
ApplicantRoclub GmbH
Decision Date2025-02-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
rTOP is the device name listed in this FDA 510(k) record. The listed applicant is Roclub GmbH. It received FDA 510(k) clearance on 2025-02-04 under 510(k) 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. The listed applicant is Roclub GmbH. The 510(k) number is K243333.
When did rTOP receive FDA 510(k) clearance?
rTOP received FDA 510(k) clearance on 2025-02-04, under 510(k) number K243333.
Who is the listed applicant for rTOP?
The FDA 510(k) record lists Roclub GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for rTOP?
The FDA product code for rTOP is LLZ.
Related Devices (Code: LLZ)
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.
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.