Byrne Medical, Inc.
Houston, TX, US
Byrne Medical, Inc. appears in FDA device records in Houston, TX. 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 Byrne Medical, Inc. between 2003 and 2012. The busiest year on record is 2009, with 4. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2006 | 1 |
| 2009 | 4 |
| 2010 | 3 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | FCX | Substantially Equivalent | |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | OCX | Substantially Equivalent | |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | OCX | Substantially Equivalent | |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | ODC | Substantially Equivalent | |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | ODC | Substantially Equivalent | |
| K093665 | ENDO SMARTCAP | FAJ | Substantially Equivalent | |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | FBK | Substantially Equivalent | |
| K092429 | ENDOGATOR | FEQ | Substantially Equivalent | |
| K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) | ODC | Substantially Equivalent | |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | OCX | Substantially Equivalent | |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | OCX | Substantially Equivalent | |
| K031773 | ENDO GATOR SYSTEM | OCX | 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