INSTRUMENTS FOR MICRO ANASTOMOSIS— 510(k) K843100

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K843100 for INSTRUMENTS FOR MICRO ANASTOMOSIS, Substantially Equivalent on 1984-09-27. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1984-08-07
Decision date: 1984-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.