EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX— 510(k) K120857
Substantially EquivalentNcontact Surgical, Inc.
FDA 510(k) clearance K120857 for EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX, Substantially Equivalent on 2012-11-13. Applicant: Ncontact Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ncontact Surgical, Inc.
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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More clearances from Ncontact Surgical, Inc.
view all- K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
- K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
- K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021; CSK-022; CSK-023; CSK-025
- K071819 — NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
- K062539 — NCONTACT COAGULATION SYSTEM KIT
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.