Decision Date2024-07-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
P-SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Oui Medical, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241502. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the P-SCOPE?
P-SCOPE is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Oui Medical, Inc.. The 510(k) number is K241502.
When did P-SCOPE receive FDA 510(k) clearance?
P-SCOPE received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241502.
Who is the listed applicant for P-SCOPE?
The FDA 510(k) record lists Oui Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for P-SCOPE?
The FDA product code for P-SCOPE is GCJ.
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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.