K893707

Substantially Equivalent

AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: DRC
Advisory panel: Cardiovascular
Date received: 1989-05-18
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.