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FDA 510(k)

SINUSPRIME Dilation System

K-Number: K201398 · 2020-10-15

ApplicantStryker Ent
Decision Date2020-10-15
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUSPRIME Dilation System is a medical device manufactured by Stryker Ent. It received FDA 510(k) clearance on 2020-10-15 under approval number K201398. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUSPRIME Dilation System?

SINUSPRIME Dilation System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Stryker Ent. The 510(k) number is K201398.

When was SINUSPRIME Dilation System approved by the FDA?

SINUSPRIME Dilation System received FDA 510(k) clearance on 2020-10-15, under approval number K201398.

What company makes SINUSPRIME Dilation System?

SINUSPRIME Dilation System is manufactured by Stryker Ent.

What is the FDA product code for SINUSPRIME Dilation System?

The FDA product code for SINUSPRIME Dilation System is LRC.

Related Clinical Trials

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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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