AXCESS SOFT TIP WIRE GUIDE— 510(k) K122816

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K122816 for AXCESS SOFT TIP WIRE GUIDE, Substantially Equivalent on 2012-10-09. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: 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

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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.