Geiger Medical Technologies, Inc.: FDA clearances and approvals
Geiger Medical Technologies, Inc. has 5 FDA 510(k) clearances (first 1999, latest 2000), across 2 product codes in 2 review panels. Median 510(k) review time: 56 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 | 4 | 4 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
Review panels
Most recent Geiger Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | HQO | 2000-10-23 | 83 |
| K001029 | GEIGER NEEDLE ADAPTER, MODEL 406 | GEI | 2000-05-23 | 54 |
| K994075 | GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 | GEI | 1999-12-27 | 25 |
| K992149 | GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 | GEI | 1999-08-19 | 56 |
| K983852 | BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 | GEI | 1999-01-28 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Geiger Medical Technologies, 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 Geiger Medical Technologies, Inc. have?
Geiger Medical Technologies, Inc. has 5 FDA 510(k) clearances (first 1999, latest 2000), across 2 product codes in 2 review panels.
How long does FDA take to clear Geiger Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Geiger Medical Technologies, Inc.'s cleared 510(k)s is 56 days.
What devices does Geiger Medical Technologies, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); HQO (Unit, Cautery, Thermal, Ac-Powered, 1).
Has Geiger Medical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Geiger Medical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Geiger Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Geiger Medical Technologies, 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.