Safety Lancet
K-Number: K223208 · 2023-02-10
ApplicantSuzhou Zhenwu Medical Co., Ltd.
Decision Date2023-02-10
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Safety Lancet is a medical device manufactured by Suzhou Zhenwu Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under approval number K223208. 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 Safety Lancet?
Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Suzhou Zhenwu Medical Co., Ltd.. The 510(k) number is K223208.
When was Safety Lancet approved by the FDA?
Safety Lancet received FDA 510(k) clearance on 2023-02-10, under approval number K223208.
What company makes Safety Lancet?
Safety Lancet is manufactured by Suzhou Zhenwu Medical Co., Ltd..
What is the FDA product code for Safety Lancet?
The FDA product code for Safety Lancet is FMK.
Related Devices (Code: FMK)
K153670Genteel Lancing DeviceGenteel, LLC
K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd.
K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.
K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.
K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc.
K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel LancetsBecton, Dickinson and Company
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.