Decision Date2026-08-07
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Zamenix™ P is the device name listed in this FDA 510(k) record. The listed applicant is Roen Surgical, Inc.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K253505. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zamenix™ P?
Zamenix™ P is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Roen Surgical, Inc.. The 510(k) number is K253505.
When did Zamenix™ P receive FDA 510(k) clearance?
Zamenix™ P received FDA 510(k) clearance on 2026-08-07, under 510(k) number K253505.
Who is the listed applicant for Zamenix™ P?
The FDA 510(k) record lists Roen Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zamenix™ P?
The FDA product code for Zamenix™ P is FGB.
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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.