FOREIGN BODY HOOD— 510(k) K130148

Name: FDA 510(k) clearance K130148
Creator: U.S. Food and Drug Administration
Published: 2013-08-07

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K130148 for FOREIGN BODY HOOD, Substantially Equivalent on 2013-08-07. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FDS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-01-22
Decision date: 2013-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.