Company ยท US
Uresil Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2010. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 |
| LJE | Catheter, Nephrostomy | 5 |
| DQY | Catheter, Percutaneous | 3 |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | 3 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| DXE | Catheter, Embolectomy | 2 |
| EXF | Bag, Bile Collecting | 2 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 |
| DQT | Occluder, Catheter Tip | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DWQ | Stripper, Vein, External | 1 |
| DYB | Introducer, Catheter | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
| GBX | Catheter, Irrigation | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2010 | K093653 | URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK Uresil, LLC | KNT |
| Dec 20, 2005 | K053245 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER Uresil, LLC | FGE |
| Aug 19, 2004 | K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY Uresil, LLC | GBO |
| Jun 13, 2002 | K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C Uresil, L.P. | GBO |
| Jan 4, 2001 | K003753 | GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE Uresil Corp. | FGE |
| Nov 20, 1998 | K980278 | URESIL VASCU-FLO INFUSION CATHETER Uresil Corp. | DQY |
| Sep 10, 1998 | K981344 | URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING Uresil Corp. | LJE |
| Apr 24, 1998 | K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER Uresil Corp. | DRE |
| Apr 8, 1998 | K980889 | URESIL NEPHRO-URETERAL STENT Uresil Corp. | LJE |
| Nov 21, 1997 | K972582 | URESIL GUIDEWIRE Uresil Corp. | FGE |
| Aug 29, 1997 | K972583 | URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S Uresil Corp. | FGE |
| Sep 8, 1995 | K953923 | URESIL INTRODUCING NEEDLE Uresil Corp. | KNW |
| Jul 10, 1995 | K945934 | URESIL(R) GUIDEWIRE Uresil Corp. | DQX |
| Jun 6, 1995 | K942688 | NEPHRO-URETERAL STENT Uresil Corp. | LJE |
| Oct 28, 1994 | K944784 | MINI-OP LAPAROSCOPIC LASSO Uresil Corp. | GEI |
| Sep 21, 1994 | K942191 | URESIL DILATOR Uresil Corp. | DYB |
| Jun 21, 1994 | K940505 | ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL) Uresil Corp. | HET |
| Oct 8, 1993 | K921417 | URESIL LAPAROSCOPIC RETRACTOR Uresil Corp. | HET |
| Aug 11, 1993 | K925117 | URESIL ABSCESS DRIANAGE AND IRRIGATION SET Uresil Corp. | GBX |
| Jul 13, 1993 | K923096 | URESIL BILLIARY CATHETER Uresil Corp. | FGE |
| May 26, 1993 | K930011 | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS Uresil Corp. | MGZ |
| Dec 15, 1992 | K923219 | URESIL SPECIMEN RETRIEVAL BAG Uresil Corp. | GCJ |
| Sep 14, 1992 | K923097 | URESIL NEPHROSTOMY CATHETER Uresil Corp. | LJE |
| Sep 14, 1992 | K920510 | URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. | GAR |
| Sep 14, 1992 | K920509 | URESIL SUMP DRAINAGE CATHETER Uresil Corp. | LJE |
| Mar 31, 1992 | K915343 | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Uresil Corp. | GCA |
| Feb 19, 1992 | K914699 | URESIL FIXATION DEVICE Uresil Corp. | FGE |
| Aug 12, 1991 | K912109 | URESIL GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. | GBO |
| Apr 18, 1991 | K905528 | URESIL VALVE CUTTER Uresil Corp. | DWQ |
| Sep 12, 1990 | K903449 | URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET Uresil Corp. | EXF |
| Jul 27, 1990 | K901882 | URESIL ENDOSCOPIC LASER OVERTUBE Uresil Corp. | KOQ |
| Jun 1, 1990 | K901844 | URESIL TRU-CLOSE DRAINAGE BAG Uresil Corp. | EXF |
| Mar 14, 1988 | K880895 | URESIL WOUND DRAIN TROCAR Uresil Corp. | GBS |
| Nov 27, 1987 | K872948 | URESIL THORA-FLO THORACENTESIS PROCEDURE KIT Uresil Corp. | JOL |
| Sep 25, 1987 | K872788 | MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN Uresil Corp. | DWF |
| Apr 22, 1987 | K871148 | URESIL CAROTID ARTERY SIZERS Uresil Corp. | DRE |
| Feb 3, 1987 | K870141 | URESIL T-SYSTEM BONE SCREWS Uresil Corp. | HWC |
| Jan 6, 1987 | K863684 | URESIL SUBCLAVIAN CATHETER Uresil Corp. | DQY |
| Jan 2, 1987 | K864007 | EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER Uresil Corp. | DXE |
| Nov 24, 1986 | K863558 | URESIL CAROTID SHUNT Uresil Corp. | DWF |
| Nov 4, 1986 | K863571 | BILIARY BALLOON CATHETER Uresil Corp. | FGE |
| Oct 10, 1986 | K863564 | URESIL IRRIGATION CATHETER Uresil Corp. | DQY |
| Oct 10, 1986 | K863559 | URESIL OCCLUSION BALLOON CATHETER Uresil Corp. | DQT |
| Oct 2, 1986 | K863563 | URESIL RADIOPAQUE SILICONE BANDS Uresil Corp. | |
| Sep 29, 1986 | K863562 | URESIL 150CC BELLOWS RESERVOIR Uresil Corp. | GCY |
| Sep 29, 1986 | K863560 | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA Uresil Corp. | GBS |
| Sep 23, 1986 | K863561 | URESIL THORACIC VENT Uresil Corp. | KDQ |
| Sep 18, 1986 | K863505 | URESIL CLOSED DRAINAGE RESERVOIR Uresil Corp. | GCY |
| Oct 2, 1981 | K812640 | URE SIL EMBOLECTOMY/THROMBECTOMY CATH Uresil Corp. | DXE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||