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510(k) Data Aggregation
K Number
K221778Device Name
Disposable Safety Lancets
Manufacturer
Suzhou Kyuan Medical Apparatus Co., Ltd.
Date Cleared
2022-10-03
(104 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Kyuan Medical Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.
Device Description
The Disposable Safety Lancets consists 7 parts, include a lancet cap, body, slide, lancet, tip cover, spring and bottom. The models of the Disposable Safety Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. Used Gamma sterilization, and are products for single use.
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K Number
K220387Device Name
Disposable Blood Lancets
Manufacturer
Suzhou Kyuan Medical Apparatus Co., Ltd.
Date Cleared
2022-08-17
(188 days)
Product Code
QRL, QRK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Kyuan Medical Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the lancet can prick the skin.
Device Description
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.
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