Stellartech Research Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Stellartech Research Corp.” (first 2000, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time under this name: 26 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 | 11 | 11 |
Review panels
Most recent Stellartech Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061544 | STELLARTECH 100 COAGULATION SYSTEM | GEI | 2006-10-13 | 130 |
| K050831 | STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A | GEI | 2005-04-12 | 11 |
| K042909 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A | GEI | 2004-11-12 | 22 |
| K041383 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 | GEI | 2004-06-14 | 20 |
| K040240 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | GEI | 2004-04-01 | 58 |
| K032721 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | GEI | 2003-10-06 | 33 |
| K032452 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 | GEI | 2003-08-21 | 10 |
| K032062 | STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) | GEI | 2003-07-29 | 26 |
| K023765 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | GEI | 2002-11-29 | 17 |
| K013139 | STELLARTECH COAGULATION SYSTEM | GEI | 2001-12-18 | 90 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stellartech Research Corp..
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 Stellartech Research Corp.?
FDA lists 11 510(k) clearances under the applicant name “Stellartech Research Corp.” (first 2000, latest 2006), 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 Stellartech Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stellartech Research Corp. is 26 days.
Which FDA product codes appear under Stellartech Research Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 11).
Next steps
- See all 11 Stellartech Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Stellartech Research Corp.'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.