EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX— 510(k) K142084

Substantially Equivalent

Ncontact Surgical, Inc.

FDA 510(k) clearance K142084 for EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX, Substantially Equivalent on 2014-10-28. Applicant: Ncontact Surgical, Inc..

Clearance details

Applicant: Ncontact Surgical, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2014-07-31
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

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Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.