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FDA 510(k)

TD-5010 Lancing Device and TD-5084 Sterile Lancets

K-Number: K221419 · 2023-01-20

ApplicantGostar Co., Ltd.
Decision Date2023-01-20
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TD-5010 Lancing Device and TD-5084 Sterile Lancets is a medical device manufactured by Gostar Co., Ltd.. It received FDA 510(k) clearance on 2023-01-20 under approval number K221419. 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 TD-5010 Lancing Device and TD-5084 Sterile Lancets?

TD-5010 Lancing Device and TD-5084 Sterile Lancets is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Gostar Co., Ltd.. The 510(k) number is K221419.

When was TD-5010 Lancing Device and TD-5084 Sterile Lancets approved by the FDA?

TD-5010 Lancing Device and TD-5084 Sterile Lancets received FDA 510(k) clearance on 2023-01-20, under approval number K221419.

What company makes TD-5010 Lancing Device and TD-5084 Sterile Lancets?

TD-5010 Lancing Device and TD-5084 Sterile Lancets is manufactured by Gostar Co., Ltd..

What is the FDA product code for TD-5010 Lancing Device and TD-5084 Sterile Lancets?

The FDA product code for TD-5010 Lancing Device and TD-5084 Sterile Lancets is QRL.

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Other Devices by Gostar Co., Ltd.

K222810TD-7301 Peak Flow meter K241843TD-7301 Spirometer (TD-7301)

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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