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FDA 510(k)

Portare System (FA-001)

K-Number: K243639 · 2025-06-05

ApplicantGrumpy Innovation, Inc.
Decision Date2025-06-05
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Portare System (FA-001) is a medical device manufactured by Grumpy Innovation, Inc.. It received FDA 510(k) clearance on 2025-06-05 under approval number K243639. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portare System (FA-001)?

Portare System (FA-001) is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Grumpy Innovation, Inc.. The 510(k) number is K243639.

When was Portare System (FA-001) approved by the FDA?

Portare System (FA-001) received FDA 510(k) clearance on 2025-06-05, under approval number K243639.

What company makes Portare System (FA-001)?

Portare System (FA-001) is manufactured by Grumpy Innovation, Inc..

What is the FDA product code for Portare System (FA-001)?

The FDA product code for Portare System (FA-001) is EOB.

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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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