DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260— 510(k) K012392

Substantially Equivalent

Pace Medical

FDA 510(k) clearance K012392 for DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260, Substantially Equivalent on 2001-09-04. Applicant: Pace Medical.

Clearance details

Applicant: Pace Medical
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2001-07-27
Decision date: 2001-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.