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FDA 510(k)

Sophy Mini Monopressure Valve (SM1)

K-Number: K250636 · 2025-11-28

ApplicantSophysa
Decision Date2025-11-28
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sophy Mini Monopressure Valve (SM1) is a medical device manufactured by Sophysa. It received FDA 510(k) clearance on 2025-11-28 under approval number K250636. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sophy Mini Monopressure Valve (SM1)?

Sophy Mini Monopressure Valve (SM1) is a medical device that received FDA 510(k) clearance on 2025-11-28. It is manufactured by Sophysa. The 510(k) number is K250636.

When was Sophy Mini Monopressure Valve (SM1) approved by the FDA?

Sophy Mini Monopressure Valve (SM1) received FDA 510(k) clearance on 2025-11-28, under approval number K250636.

What company makes Sophy Mini Monopressure Valve (SM1)?

Sophy Mini Monopressure Valve (SM1) is manufactured by Sophysa.

What is the FDA product code for Sophy Mini Monopressure Valve (SM1)?

The FDA product code for Sophy Mini Monopressure Valve (SM1) is JXG.

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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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