510(k) K242073
K242073 is an FDA 510(k) premarket notification submitted by Tsk Laboratory International Japan KK for the device "STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)". The FDA issued a decision of Substantially Equivalent on October 23, 2024. The device falls under product code QYM (Ophthalmic Needle), a Class II device regulated under 21 CFR 880.5570. Tsk Laboratory International Japan KK has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2024
- Date Received
- July 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmic Needle
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.