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FDA 510(k)

Facet 28G Universal Lancet

K-Number: K221433 · 2022-07-15

ApplicantFacet Technologies, LLC
Decision Date2022-07-15
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Facet 28G Universal Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Facet Technologies, LLC. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221433. 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 Facet 28G Universal Lancet?

Facet 28G Universal Lancet is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Facet Technologies, LLC. The 510(k) number is K221433.

When did Facet 28G Universal Lancet receive FDA 510(k) clearance?

Facet 28G Universal Lancet received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221433.

Who is the listed applicant for Facet 28G Universal Lancet?

The FDA 510(k) record lists Facet Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Facet 28G Universal Lancet?

The FDA product code for Facet 28G Universal Lancet is QRK.

Other records listing Facet Technologies, LLC 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.

K232912Facet Aurora Reusable Lancet BaseK223370NeatNick Heel Safety LancetK223099Facet Manatee Reusable Lancing BaseK222539Facet Blood Lancets

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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