K242073
- 510(k) number
- K242073
- Device name
- STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
- Applicant
- Tsk Laboratory International Japan KK JP
- Product code
- QYM — Ophthalmic Needle
- Decision date
- 2024-10-23
- Date received
- 2024-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242073.pdf
Official FDA record: K242073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.