K122816

Substantially Equivalent

AXCESS SOFT TIP WIRE GUIDE

Applicant: Wilson-Cook Medical, Inc.
Product code: OCY
Advisory panel: Gastroenterology, Urology
Date received: 2012-09-14
Decision date: 2012-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.