Accuject Refra Injector AR2900— 510(k) K231106

Substantially Equivalent

Medicel AG

FDA 510(k) clearance K231106 for Accuject Refra Injector AR2900, Substantially Equivalent on 2023-09-19. Applicant: Medicel AG.

Clearance details

Applicant: Medicel AG
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2023-04-19
Decision date: 2023-09-19
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.