Crospon, Ltd.
Bonita Springs, FL, US
Crospon, Ltd. appears in FDA device records in Bonita Springs, FL. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Crospon, Ltd. between 2009 and 2019. The busiest year on record is 2011, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183072 | EndoFLIP System | FFX | Substantially Equivalent | |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | PIE | Substantially Equivalent | |
| K170833 | EndoFLIP® System with FLIP Topography module | FFX | Substantially Equivalent | |
| K160725 | EndoFLIP | FFX | Substantially Equivalent | |
| K142000 | ESOFLIP ES | PIE | Substantially Equivalent | |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | PID | Substantially Equivalent | |
| K130906 | ENDOFLIP CATHETER | FFX | Substantially Equivalent | |
| K120997 | BAROSTAT SOFTWARE OPTION | FFX | Substantially Equivalent | |
| K110531 | ENDOFLIP ECD | FED | Substantially Equivalent | |
| K110529 | ENDOFLIP GASTRIC TUBE | KNT | Substantially Equivalent | |
| K102214 | ENDO FLIP | FFX | Substantially Equivalent | |
| K092850 | ENDOFLIP | FFX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain