Starion Instruments: FDA clearances and approvals
Starion Instruments has 13 FDA 510(k) clearances (first 1999, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time: 55 days. openFDA lists 3 product recalls by a recalling firm named Starion Instruments.
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 | 6 | 6 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 3 | 3 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 3 | 3 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
Review panels
Most recent Starion Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | HQO | 2007-04-13 | 15 |
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS | GEI | 2006-10-10 | 67 |
| K050308 | THERMAL CAUTERY PROBE | HQR | 2005-02-25 | 17 |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | HQO | 2004-12-09 | 24 |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | HQP | 2000-10-20 | 64 |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | GEI | 2000-06-14 | 55 |
| K001262 | THERMAL CAUTERY FORCEPS | GEI | 2000-06-14 | 56 |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | HQO | 2000-06-14 | 86 |
| K000296 | STARION CAUTERY HOOK | GEI | 2000-03-07 | 36 |
| K000250 | CAUTERY FORCEPS WITH FOOTSWITCH | GEI | 2000-03-07 | 40 |
3 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2010-03-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Starion Instruments have?
Starion Instruments has 13 FDA 510(k) clearances (first 1999, latest 2007), across 4 product codes in 2 review panels.
How long does FDA take to clear Starion Instruments's 510(k)s?
The median time from FDA receipt to decision across Starion Instruments's cleared 510(k)s is 55 days.
What devices does Starion Instruments make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); HQO (Unit, Cautery, Thermal, Ac-Powered, 3); HQP (Unit, Cautery, Thermal, Battery-Powered, 3).
Has Starion Instruments had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Starion Instruments; the most recent began 2010-03-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Starion Instruments clearances with predicates and recalls
- Run predicate analysis for product code GEI, Starion Instruments's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.