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FDA 510(k)

Precision Ideal Eyes Arthroscopes

K-Number: K183470 · 2019-01-07

ApplicantStryker
Decision Date2019-01-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precision Ideal Eyes Arthroscopes is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-01-07 under 510(k) number K183470. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Ideal Eyes Arthroscopes?

Precision Ideal Eyes Arthroscopes is a medical device that received FDA 510(k) clearance on 2019-01-07. The listed applicant is Stryker. The 510(k) number is K183470.

When did Precision Ideal Eyes Arthroscopes receive FDA 510(k) clearance?

Precision Ideal Eyes Arthroscopes received FDA 510(k) clearance on 2019-01-07, under 510(k) number K183470.

Who is the listed applicant for Precision Ideal Eyes Arthroscopes?

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 Ideal Eyes Arthroscopes?

The FDA product code for Precision Ideal Eyes Arthroscopes is HRX.

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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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