Decision Date2025-07-30
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TSK Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory, Japan. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K250127. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TSK Syringe?
TSK Syringe is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Tsk Laboratory, Japan. The 510(k) number is K250127.
When did TSK Syringe receive FDA 510(k) clearance?
TSK Syringe received FDA 510(k) clearance on 2025-07-30, under 510(k) number K250127.
Who is the listed applicant for TSK Syringe?
The FDA 510(k) record lists Tsk Laboratory, Japan as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TSK Syringe?
The FDA product code for TSK Syringe is QNQ.
Other records listing Tsk Laboratory, Japan 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: QNQ)
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.
K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250138Small Volume 0.2mL SyringeProsum Medical LimitedK242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd
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.