NanoDrop Lancet
K-Number: K223826 · 2024-02-22
ApplicantDrawbridge Health, Inc.
Decision Date2024-02-22
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NanoDrop Lancet is a medical device manufactured by Drawbridge Health, Inc.. It received FDA 510(k) clearance on 2024-02-22 under approval number K223826. 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 NanoDrop Lancet?
NanoDrop Lancet is a medical device that received FDA 510(k) clearance on 2024-02-22. It is manufactured by Drawbridge Health, Inc.. The 510(k) number is K223826.
When was NanoDrop Lancet approved by the FDA?
NanoDrop Lancet received FDA 510(k) clearance on 2024-02-22, under approval number K223826.
What company makes NanoDrop Lancet?
NanoDrop Lancet is manufactured by Drawbridge Health, Inc..
What is the FDA product code for NanoDrop Lancet?
The FDA product code for NanoDrop Lancet is FMK.
Other Devices by Drawbridge Health, Inc.
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.