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

Substantially Equivalent

Erbe USA, Inc.

Clearance details

Applicant: Erbe USA, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2010-12-17
Decision date: 2011-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

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.