Gallini Intl., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Gallini Intl., Inc.” (first 1996, latest 1997), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 147 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 4 | 4 |
| FCG | Biopsy Needle | 3 | 3 |
Review panels
Most recent Gallini Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970872 | PAN (CHIBA ASPIRATING NEEDLE) | KNW | 1997-05-21 | 72 |
| K970871 | TR NEEDLE | KNW | 1997-05-21 | 72 |
| K964777 | TZ | KNW | 1997-01-03 | 37 |
| K962570 | ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE | FCG | 1996-11-27 | 149 |
| K962569 | BIOMID BONE MARROW BIOPSY NEEDLE | FCG | 1996-11-27 | 149 |
| K962568 | ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES | FCG | 1996-11-25 | 147 |
| K961407 | SPEED-CUT | KNW | 1996-11-21 | 224 |
Recalls
openFDA lists no recalls under a recalling firm named Gallini Intl., 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.
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.
- Gallini U.S., LLC (10 510(k)s)
- Gallini Medical Devices, Srl (1 510(k)s)
- Gallini S.R.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gallini Intl., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Gallini Intl., Inc.” (first 1996, latest 1997), across 2 product codes in 2 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 Gallini Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gallini Intl., Inc. is 147 days.
Which FDA product codes appear under Gallini Intl., Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 4); FCG (Biopsy Needle, 3).
Next steps
- See all 7 Gallini Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Gallini Intl., 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.