Sopro
Mt. Laurel, NJ, US
Sopro appears in FDA device records in Mt. Laurel, NJ. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Sopro between 2007 and 2013. The busiest year on record is 2007, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121685 | SOPROCARE | NBL | Substantially Equivalent | |
| K103813 | SOPRO 281 | NTN | Substantially Equivalent | |
| K092329 | SOPIX 2 | MUH | Substantially Equivalent | |
| K092583 | SOPROLIFE | NBL | Substantially Equivalent | |
| K082796 | SOPRO 184 CAMERA | GCJ | Substantially Equivalent | |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | HRX | Substantially Equivalent | |
| K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | HIF | Substantially Equivalent | |
| K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE | GCJ | Substantially Equivalent | |
| K070102 | SOPRO 162 CAMERA | GCJ | 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