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FDA 510(k)

Single Use Injector

K-Number: K192498 · 2020-04-28

ApplicantOlympus Medical Systems Corp.
Decision Date2020-04-28
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Injector is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-04-28 under approval number K192498. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Injector?

Single Use Injector is a medical device that received FDA 510(k) clearance on 2020-04-28. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K192498.

When was Single Use Injector approved by the FDA?

Single Use Injector received FDA 510(k) clearance on 2020-04-28, under approval number K192498.

What company makes Single Use Injector?

Single Use Injector is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Injector?

The FDA product code for Single Use Injector is FBK.

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Related Devices (Code: FBK)

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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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