Gyrus Medical, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Gyrus Medical, Inc.” (first 1990, latest 2005), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
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 | 16 | 16 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| FJL | Resectoscope | 1 | 1 |
| JRE | Refractometer For Clinical Use | 1 | 1 |
Review panels
- General and Plastic Surgery (16)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
Most recent Gyrus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | GEI | 2005-11-09 | 251 |
| K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | GEI | 2005-10-25 | 244 |
| K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM | GEI | 2005-03-02 | 219 |
| K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA | GEI | 2004-10-22 | 128 |
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | 2004-09-10 | 120 |
| K024286 | GYRUS OPEN FORCEPS | GEI | 2003-11-17 | 329 |
| K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | GEI | 2003-07-21 | 108 |
| K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK | GEI | 2003-05-21 | 47 |
| K031081 | EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS | GEI | 2003-05-21 | 47 |
| K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE | GEI | 2003-05-21 | 47 |
13 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2014-08-27.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gyrus Acmi, Inc. (43 510(k)s)
- Gyrus Ent LLC (28 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gyrus Medical, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Gyrus Medical, Inc.” (first 1990, latest 2005), across 5 product codes in 4 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 Gyrus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gyrus Medical, Inc. is 108 days.
Which FDA product codes appear under Gyrus Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 16); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 3); HIH (Hysteroscope (And Accessories), 2).
Next steps
- See all 23 Gyrus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Gyrus Medical, Inc.'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.