Galenica Enterprises, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Galenica Enterprises, Inc.” (first 1984, latest 1994), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | 1 | 1 |
| GDI | Dissector, Surgical, General & Plastic Surgery | 1 | 1 |
| HGG | Controller, Abortion Unit, Vacuum | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | 1 | 1 |
Review panels
Most recent Galenica Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923656 | LIGHTING SOURCE SYSTEM | HIC | 1994-09-08 | 787 |
| K896383 | DISPOSABLE EXTERNAL CLAMPS | GDI | 1989-12-06 | 30 |
| K883283 | DISPOSABLE AMNIOTOME | HGG | 1988-10-18 | 75 |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | FER | 1986-06-13 | 87 |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | HIB | 1984-07-31 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Galenica Enterprises, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Galenica Enterprises, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Galenica Enterprises, Inc.” (first 1984, latest 1994), across 5 product codes in 3 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 Galenica Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Galenica Enterprises, Inc. is 83 days.
Which FDA product codes appear under Galenica Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are FER (Anoscope And Accessories, 1); GDI (Dissector, Surgical, General & Plastic Surgery, 1); HGG (Controller, Abortion Unit, Vacuum, 1).
Next steps
- See all 5 Galenica Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FER, Galenica Enterprises, 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.