ACCUJECT Injector Set 2.1-1P (LP604590)— 510(k) K252540

Substantially Equivalent

Medicel AG

FDA 510(k) clearance K252540 for ACCUJECT Injector Set 2.1-1P (LP604590), Substantially Equivalent on 2025-09-16. Applicant: Medicel AG.

Clearance details

Applicant: Medicel AG
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2025-08-12
Decision date: 2025-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altenrhein, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.