SILASTIC TENDON PASSER H.P.— 510(k) K811679

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K811679 for SILASTIC TENDON PASSER H.P., Substantially Equivalent on 1981-07-10. Applicant: Dow Corning Corp. Healthcare Industries Materials.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code HWQ
Advisory panel: Orthopedic
Date received: 1981-06-15
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

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.