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FDA 510(k)

STAT Medical Device Lancing System

K-Number: K230310 · 2023-09-08

ApplicantStat Medical Devices
Decision Date2023-09-08
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STAT Medical Device Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Stat Medical Devices. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230310. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT Medical Device Lancing System?

STAT Medical Device Lancing System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Stat Medical Devices. The 510(k) number is K230310.

When did STAT Medical Device Lancing System receive FDA 510(k) clearance?

STAT Medical Device Lancing System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230310.

Who is the listed applicant for STAT Medical Device Lancing System?

The FDA 510(k) record lists Stat Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAT Medical Device Lancing System?

The FDA product code for STAT Medical Device Lancing System is QRK.

Other records listing Stat Medical Devices 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.

K222617EasyTouch Lancing DeviceK223815ONE DROP Lancing Device

Related Devices (Code: QRK)

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.

K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K250016droplet® personal lancetsHtl-Strefa S.AK244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)SteriLance Medical (Suzhou), Inc.K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.

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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