Company ยท US
Elekta Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1999. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HCH | Clip, Aneurysm | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
| IWB | System, Radiation Therapy, Radionuclide | 1 |
| JAI | Couch, Radiation Therapy, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 1999 | K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE Elekta Instruments, Inc. | JAI |
| Oct 17, 1996 | K955064 | SPETZLER TI 100 ANEURYSM CLIP Elekta Instruments, Inc. | HCH |
| Mar 22, 1996 | K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES Elekta Instruments, Inc. | GXD |
| May 23, 1995 | K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM Elekta Instruments, Inc. | HRS |
| Jan 20, 1995 | K943468 | LEKSELL SURGIPLAN Elekta Instruments, Inc. | HAW |
| Jan 7, 1994 | K932261 | ES-100 ACCESSORIES Elekta Instruments, Inc. | HWE |
| Sep 7, 1993 | K925360 | ES-100 POWER SYSTEM, ES-100 SERIES Elekta Instruments, Inc. | GEY |
| Jan 23, 1992 | K914808 | LEKSELL GAMMAPLAN (LGP) Elekta Instruments, Inc. | IWB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||