Navarre Biomedical , Ltd.: FDA clearances and approvals
Navarre Biomedical , Ltd. has 9 FDA 510(k) clearances (first 1994, latest 1996), across 5 product codes in 3 review panels. Median 510(k) review time: 68 days.
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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | 5 | 5 |
| EXF | Bag, Bile Collecting | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
Most recent Navarre Biomedical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955110 | NAVARRE PERCUTANEOUS BILIARY DRAINAGE | FGE | 1996-11-07 | 365 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | GBX | 1996-02-07 | 68 |
| K945909 | NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER | KRA | 1995-06-02 | 182 |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | GBX | 1995-05-15 | 21 |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | GBX | 1995-04-24 | 25 |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | EXF | 1994-09-08 | 42 |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | KGZ | 1994-07-08 | 56 |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | GBX | 1994-03-28 | 244 |
| K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET | GBX | 1994-01-27 | 254 |
Recalls
openFDA lists no recalls under a recalling firm named Navarre Biomedical , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Navarre Biomedical , Ltd. have?
Navarre Biomedical , Ltd. has 9 FDA 510(k) clearances (first 1994, latest 1996), across 5 product codes in 3 review panels.
How long does FDA take to clear Navarre Biomedical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Navarre Biomedical , Ltd.'s cleared 510(k)s is 68 days.
What devices does Navarre Biomedical , Ltd. make?
Its most frequent FDA product codes are GBX (Catheter, Irrigation, 5); EXF (Bag, Bile Collecting, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Has Navarre Biomedical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Navarre Biomedical , Ltd. Related entities may recall under other names.
Next steps
- See all 9 Navarre Biomedical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GBX, Navarre Biomedical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.