Titan SGS— 510(k) K210278

Name: FDA 510(k) clearance K210278
Creator: U.S. Food and Drug Administration
Published: 2021-04-28

Substantially Equivalent

Standard Bariatrics

FDA 510(k) clearance K210278 for Titan SGS, Substantially Equivalent on 2021-04-28. Applicant: Standard Bariatrics. Device class: 2.

Clearance details

Applicant: Standard Bariatrics
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2021-02-01
Decision date: 2021-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.