Bookwalter Gordon Adjustable Compression Element— 510(k) K143078

Substantially Equivalent

Symmetry Surgical

FDA 510(k) clearance K143078 for Bookwalter Gordon Adjustable Compression Element, Substantially Equivalent on 2015-05-14. Applicant: Symmetry Surgical.

Clearance details

Applicant: Symmetry Surgical
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2014-10-27
Decision date: 2015-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antioch, TN, 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.