GENERAL AND PLASTIC SURGERY— 510(k) K140835

Name: FDA 510(k) clearance K140835
Creator: U.S. Food and Drug Administration
Published: 2014-05-20

Substantially Equivalent

Scion Medical Technologies, LLC

FDA 510(k) clearance K140835 for GENERAL AND PLASTIC SURGERY, Substantially Equivalent on 2014-05-20. Applicant: Scion Medical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Scion Medical Technologies, LLC
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2014-04-02
Decision date: 2014-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.