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FDA 510(k)

Lancing device

K-Number: K221970 · 2022-08-30

ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2022-08-30
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lancing device is a medical device manufactured by SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-08-30 under approval number K221970. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lancing device?

Lancing device is a medical device that received FDA 510(k) clearance on 2022-08-30. It is manufactured by SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221970.

When was Lancing device approved by the FDA?

Lancing device received FDA 510(k) clearance on 2022-08-30, under approval number K221970.

What company makes Lancing device?

Lancing device is manufactured by SteriLance Medical (Suzhou), Inc..

What is the FDA product code for Lancing device?

The FDA product code for Lancing device is QRL.

Other Devices by SteriLance Medical (Suzhou), Inc.

K153706Insulin Pen Needle K210745Heel Incision Safety Lancet K221521Disposable Safety Lancet K221507Disposable Blood Lancet K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

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Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

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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