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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Drawbridge Health, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) 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. The listed applicant is Drawbridge Health, Inc.. The 510(k) number is K223826.

When did NanoDrop Lancet receive FDA 510(k) clearance?

NanoDrop Lancet received FDA 510(k) clearance on 2024-02-22, under 510(k) number K223826.

Who is the listed applicant for NanoDrop Lancet?

The FDA 510(k) record lists Drawbridge Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoDrop Lancet?

The FDA product code for NanoDrop Lancet is FMK.

Other records listing Drawbridge Health, Inc. as applicant

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.

K183230OneDraw A1C Test System

Related Devices (Code: FMK)

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.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

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.

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