Argus Medical Co., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Argus Medical Co., Inc.” (first 1995, latest 1995), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
Most recent Argus Medical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950255 | ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM | HIH | 1995-08-24 | 213 |
| K951624 | ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM | HRX | 1995-07-26 | 110 |
| K950242 | ARGUS ARTHROSCOPY INSTRUMENT SYSTEM | HRX | 1995-05-15 | 115 |
| K950297 | ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM | GCJ | 1995-03-03 | 37 |
| K946011 | ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM | EOB | 1995-02-17 | 70 |
| K950378 | ARGUS LAPAROSCOPY INSTRUMENT SYSTEM | GCJ | 1995-02-09 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Argus Medical Co., 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.
- Argus Cognitive, Inc. (2 510(k)s)
- Argus Photonics Group (2 510(k)s)
- Argus Biomedical Pty, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argus Medical Co., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Argus Medical Co., Inc.” (first 1995, latest 1995), across 4 product codes in 4 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 Argus Medical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argus Medical Co., Inc. is 90 days.
Which FDA product codes appear under Argus Medical Co., Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); HRX (Arthroscope, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1).
Next steps
- See all 6 Argus Medical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Argus Medical Co., 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.