Galileo Electro-Optics Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Galileo Electro-Optics Corp.” (first 1994, latest 1998), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 230 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FBO | Cystourethroscope | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
- Orthopedic (2)
- General and Plastic Surgery (2)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Galileo Electro-Optics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981928 | GALILEO DISPOSABLE ENDOSCOPES | GCJ | 1998-08-06 | 65 |
| K962256 | GALILEO HYSTEROSCOPES AND LAPAROSCOPES | HIH | 1996-12-06 | 177 |
| K962116 | GALILEO ENDOSCOPES | EOB | 1996-11-27 | 180 |
| K934649 | GALILEO ENDOSCOPES | FBO | 1994-10-13 | 379 |
| K934707 | GALILEO ARTHROSCOPES | HRX | 1994-10-07 | 372 |
| K936280 | GALILEO ARTHROSCOPES | HRX | 1994-07-12 | 284 |
| K936279 | GALILEO ENDOSCOPES | GCJ | 1994-05-16 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named Galileo Electro-Optics 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.
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.
- Galileo Cds, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Galileo Electro-Optics Corp.?
FDA lists 7 510(k) clearances under the applicant name “Galileo Electro-Optics Corp.” (first 1994, latest 1998), across 5 product codes in 5 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 Galileo Electro-Optics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Galileo Electro-Optics Corp. is 230 days.
Which FDA product codes appear under Galileo Electro-Optics Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); HRX (Arthroscope, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1).
Next steps
- See all 7 Galileo Electro-Optics Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Galileo Electro-Optics 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, 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.