PLC SUTURE ANCHOR— 510(k) K063726

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K063726 for PLC SUTURE ANCHOR, Substantially Equivalent on 2007-03-06. Applicant: Smith & Nephew Inc., Endoscopy Div..

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2006-12-15
Decision date: 2007-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.