PROcedure Rehearsal Studio— 510(k) K153705

Name: FDA 510(k) clearance K153705
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Substantially Equivalent

3Dsystems, Simbionix Products

FDA 510(k) clearance K153705 for PROcedure Rehearsal Studio, Substantially Equivalent on 2016-09-02. Applicant: 3Dsystems, Simbionix Products. Device class: 2.

Clearance details

Applicant: 3Dsystems, Simbionix Products
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-12-23
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Airport City, IL

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Recent devices under product code LLZ

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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.