Ncontact Surgical, Inc.
Morrisville, NC, US
Ncontact Surgical, Inc. appears in FDA device records in Morrisville, NC. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Ncontact Surgical, Inc. between 2006 and 2014. The busiest year on record is 2006, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | Substantially Equivalent | |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | Substantially Equivalent | |
| K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 | OCL | Substantially Equivalent | |
| K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | OCL | Substantially Equivalent | |
| K071819 | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 | OCL | Substantially Equivalent | |
| K063012 | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK | OCL | Substantially Equivalent | |
| K062539 | NCONTACT COAGULATION SYSTEM KIT | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain