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FDA 510(k)

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable

K-Number: K192292 · 2019-11-19

ApplicantStryker
Decision Date2019-11-19
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K192292. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable?

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Stryker. The 510(k) number is K192292.

When did L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable receive FDA 510(k) clearance?

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable received FDA 510(k) clearance on 2019-11-19, under 510(k) number K192292.

Who is the listed applicant for L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable?

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 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable?

The FDA product code for L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable is OWN.

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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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