Insulin Pen Needle
K-Number: K153706 · 2016-08-29
ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2016-08-29
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Insulin Pen Needle is a medical device manufactured by SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2016-08-29 under approval number K153706. 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 Insulin Pen Needle?
Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-08-29. It is manufactured by SteriLance Medical (Suzhou), Inc.. The 510(k) number is K153706.
When was Insulin Pen Needle approved by the FDA?
Insulin Pen Needle received FDA 510(k) clearance on 2016-08-29, under approval number K153706.
What company makes Insulin Pen Needle?
Insulin Pen Needle is manufactured by SteriLance Medical (Suzhou), Inc..
What is the FDA product code for Insulin Pen Needle?
The FDA product code for Insulin Pen Needle is FMI.
Related Clinical Trials
Other Devices by SteriLance Medical (Suzhou), Inc.
K210745Heel Incision Safety Lancet
K221521Disposable Safety Lancet
K221507Disposable Blood Lancet
K221970Lancing device
K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
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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.