Company ยท US
Chalgren Enterprises, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1999. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1999 | K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 Chalgren Enterprises, Inc. | IKT |
| Jun 13, 1996 | K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP Chalgren Enterprises, Inc. | IKT |
| Jan 29, 1996 | K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Jan 22, 1996 | K953361 | EMG DISC RECORDING ELECTRODE Chalgren Enterprises, Inc. | GXY |
| Jan 22, 1996 | K953356 | EMG RECORDING RING ELECTRODE Chalgren Enterprises, Inc. | GXY |
| Jan 22, 1996 | K953354 | EMG DISC RECORDING ELECTRODE Chalgren Enterprises, Inc. | GXY |
| Dec 6, 1995 | K952908 | EMG DISC RECORDING ELECTRODE WITH PIN Chalgren Enterprises, Inc. | GXY |
| Dec 6, 1995 | K952690 | EMG DISC RECORDING ELECTRODE WITH PIN Chalgren Enterprises, Inc. | GXY |
| Oct 31, 1995 | K953887 | RE-USABLE CONCENTRIC NEEDLE Chalgren Enterprises, Inc. | IKT |
| Oct 31, 1995 | K953886 | RE-USABLE MONOPOLAR NEEDLE Chalgren Enterprises, Inc. | IKT |
| Oct 6, 1995 | K953220 | 32MM NICKEL PLATED DISC ELECTRODE Chalgren Enterprises, Inc. | GXY |
| Oct 6, 1995 | K953219 | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN Chalgren Enterprises, Inc. | GXY |
| Dec 7, 1994 | K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING Chalgren Enterprises, Inc. | HLT |
| Aug 25, 1994 | K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Feb 12, 1993 | K924521 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Feb 10, 1993 | K925706 | REUSABLE FINGER CLIP RECORDING ELECTRODE Chalgren Enterprises, Inc. | GXY |
| Oct 5, 1992 | K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES Chalgren Enterprises, Inc. | JXE |
| Sep 11, 1992 | K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS Chalgren Enterprises, Inc. | JXE |
| Mar 16, 1992 | K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Chalgren Enterprises, Inc. | IKT |
| Mar 16, 1992 | K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS Chalgren Enterprises, Inc. | IKT |
| Dec 22, 1989 | K896370 | DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) Chalgren Enterprises, Inc. | GXZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Chalgren Enterprises Inc Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA. Terminated |
IKT | K912283 |