MITEK SUTURE RETROGRADER— 510(k) K970360

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K970360 for MITEK SUTURE RETROGRADER, Substantially Equivalent on 1997-03-10. Applicant: Mitek Products.

Clearance details

Applicant: Mitek Products
Product code: Code HWQ
Advisory panel: Orthopedic
Date received: 1997-01-31
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, 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.