Gynex Corp.
Redmond, WA, US
Gynex Corp. appears in FDA device records in Redmond, WA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Gynex Corp. in 2006.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
This record is listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0008-2013 | Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current. | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain