510(k) K870019— THE LAHR BALLOON

Substantially Equivalent

Plasco, Inc.

Clearance details

Applicant: Plasco, Inc.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1987-01-02
Decision date: 1987-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

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.