OCCLUSION CLAMP** DEVICE— 510(k) K964251

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K964251 for OCCLUSION CLAMP** DEVICE, Substantially Equivalent on 1997-05-23. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1996-10-24
Decision date: 1997-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.