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FDA 510(k)

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

K-Number: K242073 · 2024-10-23

Decision Date2024-10-23
Product CodeQYM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-10-23 under 510(k) 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. The listed applicant is Tsk Laboratory International Japan KK. The 510(k) number is K242073.

When did STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) receive FDA 510(k) clearance?

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

Who is the listed applicant for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)?

The FDA 510(k) record lists Tsk Laboratory International Japan KK as the applicant. This does not by itself establish the device manufacturer.

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 records listing Tsk Laboratory International Japan KK 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: QYM)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.