DeviceClearance

K082203

Substantially Equivalent

NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025

Applicant
Ncontact Surgical, Inc.
Product code
OCL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Morrisville, NC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCL

product code OCL
Death
34
Injury
256
Total
290

Source: openFDA MAUDE database, through . 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.