Decision Date2019-05-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SteriCap Mini Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocujet, LLC. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K183016. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SteriCap Mini Needle?
SteriCap Mini Needle is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Ocujet, LLC. The 510(k) number is K183016.
When did SteriCap Mini Needle receive FDA 510(k) clearance?
SteriCap Mini Needle received FDA 510(k) clearance on 2019-05-07, under 510(k) number K183016.
Who is the listed applicant for SteriCap Mini Needle?
The FDA 510(k) record lists Ocujet, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SteriCap Mini Needle?
The FDA product code for SteriCap Mini Needle is FMI.
Related Devices (Code: FMI)
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.
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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.