TD-5010 Lancing Device and TD-5084 Sterile Lancets
K-Number: K221419 · 2023-01-20
Device Summary
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. The listed applicant is Gostar Co., Ltd.. The 510(k) number is K221419.
When did TD-5010 Lancing Device and TD-5084 Sterile Lancets receive FDA 510(k) clearance?
TD-5010 Lancing Device and TD-5084 Sterile Lancets received FDA 510(k) clearance on 2023-01-20, under 510(k) number K221419.
Who is the listed applicant for TD-5010 Lancing Device and TD-5084 Sterile Lancets?
The FDA 510(k) record lists Gostar Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Gostar Co., Ltd. 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.
Related Devices (Code: QRL)
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.
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.