Ximed/Prosure/Injectx: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ximed/Prosure/Injectx” (first 1995, latest 2001), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Ximed/Prosure/Injectx 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002269 | ELECTROSURGICAL PROBES AND DEVICES-GELTX | GEI | 2001-01-04 | 162 |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | GAA | 2000-03-01 | 83 |
| K983765 | INJECTION NEEDLE PROBE/DEVICE-TUNIS | FBK | 1998-12-11 | 46 |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | GAA | 1998-12-11 | 88 |
| K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE | FAS | 1998-05-12 | 40 |
| K974484 | ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE | GEI | 1998-02-10 | 76 |
| K974637 | ELECTRODES/PROBES/DEVICES | FAS | 1998-01-07 | 26 |
| K962593 | ELECTROSURGICAL PROBES & DEVICES | GEI | 1996-11-12 | 133 |
| K945995 | BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS | GEI | 1995-01-31 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Ximed/Prosure/Injectx.
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 Ximed/Prosure/Injectx?
FDA lists 9 510(k) clearances under the applicant name “Ximed/Prosure/Injectx” (first 1995, latest 2001), across 4 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 Ximed/Prosure/Injectx?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ximed/Prosure/Injectx is 83 days.
Which FDA product codes appear under Ximed/Prosure/Injectx?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); FAS (Electrode, Electrosurgical, Active, Urological, 2); GAA (Needle, Aspiration And Injection, Disposable, 2).
Next steps
- See all 9 Ximed/Prosure/Injectx clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ximed/Prosure/Injectx'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.