SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM— 510(k) K000608

Substantially Equivalent

Std Mfg., Inc.

FDA 510(k) clearance K000608 for SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM, Substantially Equivalent on 2000-03-07. Applicant: Std Mfg., Inc..

Clearance details

Applicant: Std Mfg., Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2000-02-23
Decision date: 2000-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, 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.