Bip USA, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bip USA, Inc.” (first 1993, latest 2003), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 138 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | 2 | 2 |
| KNW | Instrument, Biopsy | 2 | 2 |
| FCG | Biopsy Needle | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
| MJG | Device, Percutaneous, Biopsy | 1 | 1 |
Review panels
Most recent Bip USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024089 | VACUFLASH BIOPSY SYSTEM | KNW | 2003-03-11 | 90 |
| K934371 | BIP MULTI MODIFICATION | KNW | 1994-04-28 | 233 |
| K934370 | BIP BIOPSY NEEDLE MODIFICATION | FCG | 1994-03-07 | 181 |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | GDF | 1994-02-17 | 97 |
| K925870 | SPACER | MJG | 1993-05-19 | 181 |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | GDF | 1993-04-06 | 138 |
| K925874 | BREAST STABILIZER | MDM | 1993-03-16 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Bip USA, 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 Bip USA, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bip USA, Inc.” (first 1993, latest 2003), across 5 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 Bip USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bip USA, Inc. is 138 days.
Which FDA product codes appear under Bip USA, Inc.?
The most frequent FDA product codes under this applicant name are GDF (Guide, Needle, Surgical, 2); KNW (Instrument, Biopsy, 2); FCG (Biopsy Needle, 1).
Next steps
- See all 7 Bip USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDF, Bip USA, 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.