Padlock Clip defect closure system, Padlock Pro-Select defect closure device— 510(k) K192722

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K192722 for Padlock Clip defect closure system, Padlock Pro-Select defect closure device, Substantially Equivalent on 2019-10-24. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-27
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.