Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

K-Number: K242073 · 2024-10-23

ApplicantTsk Laboratory International Japan KK
Decision Date2024-10-23
Product CodeQYM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is a medical device manufactured by Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-10-23 under approval number K242073. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Tsk Laboratory International Japan KK. The 510(k) number is K242073.

When was STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) approved by the FDA?

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) received FDA 510(k) clearance on 2024-10-23, under approval number K242073.

What company makes STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is manufactured by Tsk Laboratory International Japan KK.

What is the FDA product code for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

The FDA product code for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is QYM.

Other Devices by Tsk Laboratory International Japan KK

K231734STERiJECT Low Dead Space, STERiJECT The Invisible Needle

Related Devices (Code: QYM)

K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.

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.

↑