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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ent. It received FDA 510(k) clearance on 2020-10-15 under 510(k) 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. The listed applicant is Stryker Ent. The 510(k) number is K201398.

When did SINUSPRIME Dilation System receive FDA 510(k) clearance?

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

Who is the listed applicant for SINUSPRIME Dilation System?

The FDA 510(k) record lists Stryker Ent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINUSPRIME Dilation System?

The FDA product code for SINUSPRIME Dilation System is LRC.

Other records listing Stryker Ent as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLCK190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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