Motus GI Medical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Motus GI Medical Technologies , Ltd.” (first 2016, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 30 days, against 147 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 262 |
| 2017 | 1 | 43 |
| 2018 | 1 | 20 |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 1 | 37 |
| 2023 | 1 | 31 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Motus GI Medical Technologies , Ltd. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 | 7 |
Review panels
Most recent Motus GI Medical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232922 | Pure-Vu EVS System | FDF | 2023-10-20 | 31 |
| K220007 | Pure-Vu EVS System | FDF | 2022-02-10 | 37 |
| K210981 | Pure Vu System | FDF | 2021-04-29 | 28 |
| K191220 | Pure Vu System | FDF | 2019-06-06 | 30 |
| K181437 | Pure Vu System | FDF | 2018-06-21 | 20 |
| K173392 | Pure-Vu System | FDF | 2017-12-12 | 43 |
| K160015 | Pure Vu | FDF | 2016-09-22 | 262 |
Recalls
openFDA lists no recalls under a recalling firm named Motus GI Medical Technologies , Ltd..
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 Motus GI Medical Technologies , Ltd. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03503162: Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (Completed, started 2018-05-17)
- NCT03026075: Evaluation of the Performance of the Motus Cleansing System (MCS) (Completed, started 2016-12-22)
- NCT02572076: Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System (Completed, started 2016-01-31)
- NCT02387268: Evaluation of the Performance of the CleanC System-Israel (Completed, started 2015-05)
- NCT02161536: Evaluation of the Performance of the Motus Cleansing System (Completed, started 2014-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Motus GI Medical Technologies , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Motus GI Medical Technologies , Ltd.” (first 2016, latest 2023), 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 Motus GI Medical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Motus GI Medical Technologies , Ltd. is 31 days. Since 2017: 30 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Motus GI Medical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are FDF (Colonoscope And Accessories, Flexible/Rigid, 7).
Next steps
- See all 7 Motus GI Medical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FDF, Motus GI Medical Technologies , Ltd.'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.