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FDA 510(k)

Single Use Injector

K-Number: K192498 · 2020-04-28

Decision Date2020-04-28
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Injector is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-04-28 under 510(k) 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. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K192498.

When did Single Use Injector receive FDA 510(k) clearance?

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

Who is the listed applicant for Single Use Injector?

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

What is the FDA product code for Single Use Injector?

The FDA product code for Single Use Injector is FBK.

Other records listing Olympus Medical Systems Corp. 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.

View all 112 devices →

Related Devices (Code: FBK)

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.

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.