Ncontact Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ncontact Surgical, Inc.” (first 2006, latest 2014), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 237 |
| 2013 | 0 | — |
| 2014 | 1 | 89 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Ncontact Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | 2014-10-28 | 89 |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | 2012-11-13 | 237 |
| K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 | OCL | 2009-02-17 | 21 |
| K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | OCL | 2008-12-30 | 147 |
| K071819 | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 | OCL | 2007-07-26 | 23 |
| K063012 | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK | OCL | 2006-12-01 | 60 |
| K062539 | NCONTACT COAGULATION SYSTEM KIT | GEI | 2006-12-01 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Ncontact Surgical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ncontact Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ncontact Surgical, Inc.” (first 2006, latest 2014), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ncontact Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ncontact Surgical, Inc. is 89 days.
Which FDA product codes appear under Ncontact Surgical, Inc.?
The most frequent FDA product codes under this applicant name are OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 7 Ncontact Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCL, Ncontact Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.