ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES— 510(k) K103696

Substantially Equivalent

Erbe USA, Inc.

FDA 510(k) clearance K103696 for ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES, Substantially Equivalent on 2011-03-22. Applicant: Erbe USA, Inc.. Device class: 2.

Clearance details

Applicant
Erbe USA, Inc.
Product code
Code FEQ
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marietta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FEQ

product code FEQ
Malfunction
1,135
Total
1,135

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.