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FDA 510(k)

P-SCOPE

K-Number: K241502 · 2024-07-24

ApplicantOui Medical, Inc.
Decision Date2024-07-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

P-SCOPE is a medical device manufactured by Oui Medical, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval 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. It is manufactured by Oui Medical, Inc.. The 510(k) number is K241502.

When was P-SCOPE approved by the FDA?

P-SCOPE received FDA 510(k) clearance on 2024-07-24, under approval number K241502.

What company makes P-SCOPE?

P-SCOPE is manufactured by Oui Medical, Inc..

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.

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