DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING— 510(k) K931056

Substantially Equivalent

American Cyanamid Co.

FDA 510(k) clearance K931056 for DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING, Substantially Equivalent on 1993-07-08. Applicant: American Cyanamid Co..

Clearance details

Applicant: American Cyanamid Co.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1993-03-01
Decision date: 1993-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.