CLEANING BRUSH— 510(k) K924103

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K924103 for CLEANING BRUSH, Substantially Equivalent on 1992-11-16. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant
United States Endoscopy Group, Inc.
Product code
Code FEB
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waite Hill, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FEB

product code FEB
Malfunction
3,879
Total
3,879

Source: openFDA MAUDE database, through . 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.