HT-WEDGE— 510(k) K121287

Name: FDA 510(k) clearance K121287
Creator: U.S. Food and Drug Administration
Published: 2012-10-03

Substantially Equivalent

D.T. Davis Enterprises Ltd. T/A Hovertech Int'L

FDA 510(k) clearance K121287 for HT-WEDGE, Substantially Equivalent on 2012-10-03. Applicant: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L. Device class: 2.

Clearance details

Applicant: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
Product code: Code FNG
Device class: Class 2
Regulation: 21 CFR 880.5500
Advisory panel: General Hospital
Date received: 2012-04-30
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNG

product code FNG

Death: 4
Total: 4

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.