ROYALE AE 9036 LSP INJECTOR— 510(k) K073010

Substantially Equivalent

Asico, LLC

FDA 510(k) clearance K073010 for ROYALE AE 9036 LSP INJECTOR, Substantially Equivalent on 2007-11-07. Applicant: Asico, LLC.

Clearance details

Applicant: Asico, LLC
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2007-10-25
Decision date: 2007-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

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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.