PROCEDURE REHEARSAL STUDIO(TM)— 510(k) K112387

Substantially Equivalent

Simbionix , Ltd.

FDA 510(k) clearance K112387 for PROCEDURE REHEARSAL STUDIO(TM), Substantially Equivalent on 2011-12-27. Applicant: Simbionix , Ltd..

Clearance details

Applicant: Simbionix , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-08-18
Decision date: 2011-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Chalotte, NC, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.