510(k) K160170— Lehman Manometry Catheter

Substantially Equivalent

Wilson-Cook Medical, Inc.

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2016-01-27
Decision date: 2016-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

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.