Company ยท US
Promex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2002. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNW | Instrument, Biopsy | 5 |
| FCG | Biopsy Needle | 4 |
| DYB | Introducer, Catheter | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 |
| GDF | Guide, Needle, Surgical | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| MIA | Needle, Spinal, Short Term | 1 |
| NEU | Marker, Radiographic, Implantable | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2002 | K023450 | BIOPSY SITE TISSUE MARKER DEVICE Promex, Inc. | NEU |
| Nov 6, 2002 | K022634 | CO-AXIAL INTRODUCER NEEDLE Promex, Inc. | DYB |
| Jul 24, 2001 | K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE Promex, Inc. | KNW |
| Jun 22, 2001 | K011270 | AUTOMATED CORE BIOPSY DEVICE Promex, Inc. | FCG |
| May 1, 2000 | K001132 | BONE BIOPSY NEEDLE Promex, Inc. | KNW |
| Jan 7, 2000 | K994272 | AUTOMATED CORE BIOPSY DEVICE Promex, Inc. | KNW |
| Dec 6, 1999 | K993435 | MANUAL BONE MARROW BIOPSY DEVICE Promex, Inc. | KNW |
| Nov 21, 1997 | K973184 | PROSTATE SEEDING NEEDLE Promex, Inc. | IWJ |
| Sep 29, 1997 | K972865 | PROMEX ENT TISSUE REMOVAL SYSTEM Promex, Inc. | ERL |
| Jun 14, 1996 | K961078 | AUTOMATED VITRECTOMY DEVICE Promex, Inc. | HQE |
| Mar 18, 1996 | K960023 | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS Promex, Inc. | JDW |
| Feb 28, 1996 | K960405 | SPINAL NEEDLE Promex, Inc. | MIA |
| Jan 22, 1996 | K955168 | SURGICAL CUTTER Promex, Inc. | GEI |
| Sep 29, 1995 | K954265 | TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE Promex, Inc. | KNW |
| Sep 22, 1995 | K954231 | AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT Promex, Inc. | FCG |
| Sep 12, 1995 | K954155 | GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. | FCG |
| Dec 21, 1994 | K945146 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. | FCG |
| Nov 22, 1994 | K945124 | BREAST LESION LOCALIZATION NEEDLE Promex, Inc. | GDF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||