Medicnrg , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medicnrg , Ltd.” (first 2004, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 151 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | 5 | 5 |
Review panels
- Dental (5)
Most recent Medicnrg , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101177 | APEXNRG RIDER | LQY | 2010-10-08 | 164 |
| K080113 | APEX DAL ELECTRONIC APEX LOCATOR | LQY | 2008-02-15 | 30 |
| K071133 | APEXNRG-BLUE ELECTRONIC APEX LOCATOR | LQY | 2007-09-21 | 151 |
| K063843 | APEXNRG XFR | LQY | 2007-01-03 | 8 |
| K032743 | APEX NRG | LQY | 2004-03-15 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Medicnrg , Ltd..
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 Medicnrg , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Medicnrg , Ltd.” (first 2004, latest 2010), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicnrg , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicnrg , Ltd. is 151 days.
Which FDA product codes appear under Medicnrg , Ltd.?
The most frequent FDA product codes under this applicant name are LQY (Locator, Root Apex, 5).
Next steps
- See all 5 Medicnrg , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LQY, Medicnrg , Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.