Onux Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Onux Medical, Inc.” (first 2001, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| GDW | Staple, Implantable | 2 | 2 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| NJU | Suture, Nonabsorbable, Nitinol | 1 | 1 |
Review panels
Most recent Onux Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023372 | NON-BIOABSORBABLE STAPLE | NJU | 2002-12-27 | 80 |
| K022777 | MANUAL TOUCHE SYSTEM | GAQ | 2002-11-19 | 90 |
| K014286 | SALUTE, MODEL 3022 | GDW | 2002-03-08 | 71 |
| K010620 | ENDOSCOPIC STAPLE REMOVAL INSTRUMENT | GCJ | 2001-05-17 | 77 |
| K003522 | SALUTE | GDW | 2001-02-13 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Onux Medical, 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 Onux Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Onux Medical, Inc.” (first 2001, latest 2002), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Onux Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onux Medical, Inc. is 80 days.
Which FDA product codes appear under Onux Medical, Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 2); GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Onux Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Onux Medical, 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.