Avantis Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Avantis Medical Systems, Inc.” (first 2007, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 88 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 | 1 | 255 |
| 2015 | 0 | — |
| 2016 | 1 | 99 |
| 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 6 | 6 |
Review panels
Most recent Avantis Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | FDF | 2016-05-17 | 99 |
| K140595 | THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM | FDF | 2014-11-17 | 255 |
| K093187 | MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | FDF | 2009-11-05 | 27 |
| K091783 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM | FDF | 2009-07-07 | 20 |
| K083180 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | FDF | 2009-02-12 | 107 |
| K070330 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | FDF | 2007-04-24 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Avantis Medical Systems, 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.
Device clinical trials
An industry sponsor named Avantis Medical Systems, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01044732: Third Eye Retroscope Randomized Clinical Evaluation (Completed, started 2009-03)
- NCT00969124: Impact of Experience on Results With the Third Eye Retroscope (Completed, started 2009-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avantis Medical Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Avantis Medical Systems, Inc.” (first 2007, latest 2016), across 1 product code 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 Avantis Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avantis Medical Systems, Inc. is 88 days.
Which FDA product codes appear under Avantis Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FDF (Colonoscope And Accessories, Flexible/Rigid, 6).
Next steps
- See all 6 Avantis Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FDF, Avantis Medical Systems, 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.