NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125— 510(k) K090202
Substantially EquivalentNcontact Surgical, Inc.
FDA 510(k) clearance K090202 for NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125, Substantially Equivalent on 2009-02-17. Applicant: Ncontact Surgical, Inc..
Clearance details
- Applicant
- Ncontact Surgical, Inc.
- Product code
- Code OCL
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Morrisville, NC, US
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.