Optus, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Optus, Inc.” (first 1994, latest 1996), across 8 product codes in 6 review panels. Median 510(k) review time under this name: 180 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 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
- Ear, Nose and Throat (3)
- Orthopedic (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Optus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945264 | OPTUS OTOSCOPES | ERA | 1996-02-02 | 462 |
| K953913 | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES | HRX | 1996-01-22 | 154 |
| K945268 | OPTUS BRONCHOSCOPES | EOQ | 1995-12-21 | 419 |
| K945265 | OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES | HIH | 1995-09-12 | 319 |
| K945262 | OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES | FAJ | 1995-05-26 | 210 |
| K945267 | OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES | HRX | 1995-05-23 | 207 |
| K945266 | OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES | GCJ | 1995-02-23 | 118 |
| K944656 | OPTUS SINUSCOPES AND ACCESSORIES | EOB | 1995-01-26 | 127 |
| K945263 | OPTUS THORACOSCOPES | GCJ | 1994-12-13 | 46 |
| K945269 | OPTUS LARYNGOSCOPES | CCW | 1994-11-07 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Optus, 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 Optus, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Optus, Inc.” (first 1994, latest 1996), across 8 product codes in 6 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 Optus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optus, Inc. is 180 days.
Which FDA product codes appear under Optus, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); HRX (Arthroscope, 2); CCW (Laryngoscope, Rigid, 1).
Next steps
- See all 10 Optus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Optus, 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.