Promex, Inc.
Medical device manufacturer in Franklin, IN.
18510(k) clearances
0PMA approvals
0recalls
Device types
- KNW Instrument, Biopsy 5
- FCG Biopsy Needle 4
- GDF Guide, Needle, Surgical 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- MIA Needle, Spinal, Short Term 1
- JDW Pin, Fixation, Threaded 1
- HQE Instrument, Vitreous Aspiration And… 1
- ERL Drill, Surgical, Ent (Electric Or… 1
- IWJ System, Applicator, Radionuclide, Manual 1
- DYB Introducer, Catheter 1
- NEU Marker, Radiographic, Implantable 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | 12/19/2002SE |
| K022634 | Co-Axial Introducer NeedleDYB · Traditional | 11/06/2002SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | 07/24/2001SE |
| K011270 | Automated Core Biopsy DeviceFCG · Traditional | 06/22/2001SE |
| K001132 | Bone Biopsy NeedleKNW · Traditional | 05/01/2000SE |
| K994272 | Automated Core Biopsy DeviceKNW · Traditional | 01/07/2000SE |
| K993435 | Manual Bone Marrow Biopsy DeviceKNW · Traditional | 12/06/1999SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | 11/21/1997SE |
| K972865 | Promex ENT Tissue Removal SystemERL · Traditional | 09/29/1997SE |
| K961078 | Automated Vitrectomy DeviceHQE · Traditional | 06/14/1996SE |
| K960023 | Kirshner Wires (K-Wire) & Steinmann PinsJDW · Traditional | 03/18/1996SE |
| K960405 | Spinal NeedleMIA · Traditional | 02/28/1996SE |
| K955168 | Surgical CutterGEI · Traditional | 01/22/1996SE |
| K954265 | Trocar Style Needle/Co-Axial Introducer NeedleKNW · Traditional | 09/29/1995SE |
| K954231 | Augastroenterology-Urology Biopsy InstrumentFCG · Traditional | 09/22/1995SE |
| K954155 | Greene, Turner, Menghini Style Aspiration Biopsy NeedleFCG · Traditional | 09/12/1995SE |
| K945146 | Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy NeedleFCG · Traditional | 12/21/1994SE |
| K945124 | Breast Lesion Localization NeedleGDF · Traditional | 11/22/1994SE |