Clearance Summary
ACCUJECT Injector Set 2.1-1P (LP604590) received FDA 510(k) clearance under submission number K252540, sponsored by Medicel AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2025-09-16.
- Submission: K252540
- Applicant / Sponsor: Medicel AG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2025-09-16
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.