Electroscope, Inc.: FDA clearances and approvals
Electroscope, Inc. has 6 FDA 510(k) clearances (first 1991, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time: 163 days.
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 |
Review panels
Most recent Electroscope, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000480 | ACTIVE ELECTRODE MONITORING SYSTEM | GEI | 2000-05-02 | 78 |
| K972562 | BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED | GEI | 1998-01-16 | 191 |
| K973682 | BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, | GEI | 1997-12-18 | 83 |
| K913625 | ELECTROSCOPE MONITOR, EM-1 | GEI | 1991-12-30 | 137 |
| K912781 | ELECTROSHIELD | GEI | 1991-12-30 | 189 |
| K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD | GEI | 1991-12-30 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Electroscope, Inc..
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 Electroscope, Inc. have?
Electroscope, Inc. has 6 FDA 510(k) clearances (first 1991, latest 2000), across 1 product code in 1 review panel.
How long does FDA take to clear Electroscope, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Electroscope, Inc.'s cleared 510(k)s is 163 days.
What devices does Electroscope, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6).
Has Electroscope, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electroscope, Inc. Related entities may recall under other names.
Next steps
- See all 6 Electroscope, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Electroscope, Inc.'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.