All-Suture Dual Anchor System— 510(k) K250095

Substantially Equivalent

Suturetech, Inc.

FDA 510(k) clearance K250095 for All-Suture Dual Anchor System, Substantially Equivalent on 2025-09-05. Applicant: Suturetech, Inc..

Clearance details

Applicant: Suturetech, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2025-01-14
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.