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FDA 510(k)

EasyTouch Lancing Device

K-Number: K222617 · 2023-03-21

ApplicantStat Medical Devices
Decision Date2023-03-21
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EasyTouch Lancing Device 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 2023-03-21 under 510(k) number K222617. 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 EasyTouch Lancing Device?

EasyTouch Lancing Device is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Stat Medical Devices. The 510(k) number is K222617.

When did EasyTouch Lancing Device receive FDA 510(k) clearance?

EasyTouch Lancing Device received FDA 510(k) clearance on 2023-03-21, under 510(k) number K222617.

Who is the listed applicant for EasyTouch Lancing Device?

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 EasyTouch Lancing Device?

The FDA product code for EasyTouch Lancing Device 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.

K230310STAT Medical Device Lancing SystemK223815ONE 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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