Disposable Safety Lancet
K-Number: K221521 · 2022-10-28
ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2022-10-28
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Safety Lancet is a medical device manufactured by SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-10-28 under approval number K221521. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Safety Lancet?
Disposable Safety Lancet is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221521.
When was Disposable Safety Lancet approved by the FDA?
Disposable Safety Lancet received FDA 510(k) clearance on 2022-10-28, under approval number K221521.
What company makes Disposable Safety Lancet?
Disposable Safety Lancet is manufactured by SteriLance Medical (Suzhou), Inc..
What is the FDA product code for Disposable Safety Lancet?
The FDA product code for Disposable Safety Lancet is FMK.
Related Clinical Trials
Other Devices by SteriLance Medical (Suzhou), Inc.
K153706Insulin Pen Needle
K210745Heel Incision 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)
Related Devices (Code: FMK)
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K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.
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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.