Chalgren Enterprises, Inc.
Medical device manufacturer in Gilroy, CA.
21510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K982950 | Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550IKT · Traditional | 06/22/1999SE |
| K960591 | Re-Usable Bipolar Concentric NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPIKT · Traditional | 06/13/1996SE |
| K955335 | Disposable Hypodermic Monopolar Needle Recording ElectrodeIKT · Traditional | 01/29/1996SE |
| K953361 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
| K953356 | Emg Recording Ring ElectrodeGXY · Traditional | 01/22/1996SE |
| K953354 | Emg Disc Recording ElectrodeGXY · Traditional | 01/22/1996SE |
| K952908 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K952690 | Emg Disc Recording Electrode with PinGXY · Traditional | 12/06/1995SE |
| K953887 | Re-Usable Concentric NeedleIKT · Traditional | 10/31/1995SE |
| K953886 | Re-Usable Monopolar NeedleIKT · Traditional | 10/31/1995SE |
| K953220 | 32MM Nickel Plated Disc ElectrodeGXY · Traditional | 10/06/1995SE |
| K953219 | 22MM Stainless Steel Disc Electrode, with PinGXY · Traditional | 10/06/1995SE |
| K924277 | Disposable Hypodermic Monoplar Needle RecordingHLT · Traditional | 12/07/1994SE |
| K931029 | Disposable Concentric Needle ElectrodeIKT · Traditional | 08/25/1994SE |
| K924521 | Disposable Concentric Needle ElectrodeIKT · Traditional | 02/12/1993SE |
| K925706 | Reusable Finger Clip Recording ElectrodeGXY · Traditional | 02/10/1993SE |
| K923665 | Reusable Dual Disc Bar Recording ElectrodesJXE · Traditional | 10/05/1992SE |
| K921504 | Reusable Dual Disc Bar Electrodes, Various ModelsJXE · Traditional | 09/11/1992SE |
| K912283 | Detachable, Disposable Monopolar Needle ElectrodeIKT · Traditional | 03/16/1992SE |
| K912282 | Disposable Monopolar Needle Electrode, Var ModelsIKT · Traditional | 03/16/1992SE |
| K896370 | Disp. Concentric Needle Electrode (DCP-30, DCP-45)GXZ · Traditional | 12/22/1989SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2446-2010 | Disposable Detachable Monopolar Needle Electrode for electromyograph model number…Sterility Compromised-- Investigation found that individual packaging seals were separating, which may… | 04/12/2007Terminated |