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FDA 510(k)

Precision S 4K Sinuscope

K-Number: K191102 · 2019-09-06

ApplicantStryker
Decision Date2019-09-06
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Precision S 4K Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191102. 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 Precision S 4K Sinuscope?

Precision S 4K Sinuscope is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Stryker. The 510(k) number is K191102.

When did Precision S 4K Sinuscope receive FDA 510(k) clearance?

Precision S 4K Sinuscope received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191102.

Who is the listed applicant for Precision S 4K Sinuscope?

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

What is the FDA product code for Precision S 4K Sinuscope?

The FDA product code for Precision S 4K Sinuscope 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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