FDA 510(k)

Facet 28G Universal Lancet

K-Number: K221433 · 2022-07-15

Decision Date2022-07-15

Product CodeQRK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Facet 28G Universal Lancet is a medical device manufactured by Facet Technologies, LLC. It received FDA 510(k) clearance on 2022-07-15 under approval 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. It is manufactured by Facet Technologies, LLC. The 510(k) number is K221433.

When was Facet 28G Universal Lancet approved by the FDA?

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

What company makes Facet 28G Universal Lancet?

Facet 28G Universal Lancet is manufactured by Facet Technologies, LLC.

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

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

Other Devices by Facet Technologies, LLC

K223099Facet Manatee Reusable Lancing Base K222539Facet Blood Lancets K223370NeatNick Heel Safety Lancet K232912Facet Aurora Reusable Lancet Base

Related Devices (Code: QRK)

K221383MedtFine Blood LancetShanghai Carelife International Trading Co. , Ltd. K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. K230310STAT Medical Device Lancing SystemStat Medical Devices K230759SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)Bosungmeditech Co., Ltd. K222617EasyTouch Lancing DeviceStat Medical Devices

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.