Search Results
Found 7 results
510(k) Data Aggregation
K Number
K244031Device Name
Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2025-02-26
(58 days)
Product Code
QRK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Blood Lancet is used for capillary blood sampling.
Device Description
Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
Ask a Question
K Number
K244036Device Name
Heel Incision Safety Lancet (SteriHeel 2)
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2025-02-26
(58 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.
Device Description
Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.
Ask a Question
K Number
K233796Device Name
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2024-01-16
(48 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable safety lancet is used for capillary blood collection. The device has an integral sharps injury prevention feature.
Device Description
The Disposable Safety Lancets produced is sterile, single use, spring loaded lancets designed for capillary blood sampling. The device intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use. The device is intended to be used by professionals and lay person.
Ask a Question
K Number
K221521Device Name
Disposable Safety Lancet
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2022-10-28
(156 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature
Device Description
The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.
The device is intended to be used by professionals and individuals.
Ask a Question
K Number
K221507Device Name
Disposable Blood Lancet
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2022-08-31
(100 days)
Product Code
QRK, QRL
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Blood Lancet is used for capillary blood collection.
Device Description
Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use.
The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
Ask a Question
K Number
K210745Device Name
Heel Incision Safety Lancet
Manufacturer
SteriLance Medical (Suzhou) Inc.
Date Cleared
2021-08-26
(167 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
SteriLance Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
Device Description
Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use. Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals. Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.
Ask a Question
K Number
K153706Device Name
Insulin Pen Needle
Manufacturer
STERILANCE MEDICAL (SUZHOU) INC.
Date Cleared
2016-08-29
(250 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
STERILANCE MEDICAL (SUZHOU) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Device Description
The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.
The Pen Needle is offered in various gauge size and length.
The proposed device is available in radiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
Ask a Question
Page 1 of 1