Crospon, Ltd.: FDA clearances and approvals
Crospon, Ltd. has 12 FDA 510(k) clearances (first 2009, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time: 104 days. Since 2017 its median was 102 days, against 124 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 147 |
| 2013 | 2 | 90 |
| 2014 | 1 | 64 |
| 2015 | 0 | — |
| 2016 | 1 | 46 |
| 2017 | 2 | 80 |
| 2018 | 0 | — |
| 2019 | 1 | 102 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Crospon, Ltd.'s cleared 510(k)s took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | 7 | 7 |
| PIE | Esophageal Dilator With Balloon And Electrode Sensors | 2 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| PID | Esophageal Dilator Balloon With Or Without Electrode Sensors | 1 | 1 |
Review panels
Most recent Crospon, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183072 | EndoFLIP System | FFX | 2019-02-15 | 102 |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | PIE | 2017-11-22 | 131 |
| K170833 | EndoFLIP® System with FLIP Topography module | FFX | 2017-04-17 | 28 |
| K160725 | EndoFLIP | FFX | 2016-05-01 | 46 |
| K142000 | ESOFLIP ES | PIE | 2014-09-25 | 64 |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | PID | 2013-10-07 | 73 |
| K130906 | ENDOFLIP CATHETER | FFX | 2013-07-17 | 107 |
| K120997 | BAROSTAT SOFTWARE OPTION | FFX | 2012-08-27 | 147 |
| K110531 | ENDOFLIP ECD | FED | 2011-10-06 | 224 |
| K110529 | ENDOFLIP GASTRIC TUBE | KNT | 2011-07-22 | 148 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Crospon, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Crospon, Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01060592: LapBand Adjustment to Improve Early Weight Loss (Completed, started 2009-10)
Frequently asked questions
How many FDA 510(k) clearances does Crospon, Ltd. have?
Crospon, Ltd. has 12 FDA 510(k) clearances (first 2009, latest 2019), across 5 product codes in 1 review panel.
How long does FDA take to clear Crospon, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Crospon, Ltd.'s cleared 510(k)s is 104 days. Since 2017: 102 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Crospon, Ltd. make?
Its most frequent FDA product codes are FFX (System, Gastrointestinal Motility (Electrical), 7); PIE (Esophageal Dilator With Balloon And Electrode Sensors, 2); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1).
Has Crospon, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Crospon, Ltd. Related entities may recall under other names.
Next steps
- See all 12 Crospon, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FFX, Crospon, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.