Company ยท US
Vance Products Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1982. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAD | Stent, Ureteral | 18 |
| KOD | Catheter, Urological | 5 |
| KOE | Dilator, Urethral | 4 |
| KOB | Catheter, Suprapubic (And Accessories) | 2 |
| EXB | Collector, Ostomy | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FGI | Catheter, Urethrographic, Male | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| KNW | Instrument, Biopsy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 1982 | K820313 | VPI-FAIR URETHRAL STENT Vance Products, Inc. | KOD |
| Mar 1, 1982 | K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER Vance Products, Inc. | KOD |
| Dec 18, 1981 | K813278 | VPI URETERAL DILATATION BALLON CATHETER Vance Products, Inc. | EZN |
| Nov 16, 1981 | K812785 | VANCE-AMBROSE RESECTOSCOPE FORCEPS Vance Products, Inc. | GEN |
| Jul 31, 1981 | K812057 | VANCE CYSTOSCOPIC Vance Products, Inc. | FBK |
| Jul 10, 1981 | K811833 | VNACE FASCIAL DILATOR SET Vance Products, Inc. | KOE |
| Jun 9, 1981 | K811454 | VANCE PROSTATIC ASPIRATION SET Vance Products, Inc. | KNW |
| Mar 20, 1981 | K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET Vance Products, Inc. | KOD |
| Mar 20, 1981 | K810371 | VANCE URETHAL DILATOR SET Vance Products, Inc. | KOE |
| Mar 20, 1981 | K810370 | POLLACK CHAIN CYSOURETHROGRAM SET Vance Products, Inc. | FGI |
| Mar 20, 1981 | K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY Vance Products, Inc. | KOB |
| Mar 20, 1981 | K810367 | KISH URETHRAL ILLUMINATED CATHETER SET Vance Products, Inc. | KOD |
| Dec 22, 1980 | K803048 | VANCE UROSTOMY APPLIANCE Vance Products, Inc. | EXB |
| Dec 6, 1979 | K792221 | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE Vance Products, Inc. | KOE |
| Dec 6, 1979 | K792220 | VANCE KIDNEY BIOPSY BRUSHES Vance Products, Inc. | KOD |
| Dec 6, 1979 | K792219 | VANCE MALLEABLE TIP FILIFORM Vance Products, Inc. | KOE |
| Jul 17, 1978 | K780765 | PERCUTANEOUS SURAPUBIC CATHETER Vance Products, Inc. | KOB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2011 | Vance Products Incorporated Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN.
Used for temporary internal drainage from the ureteropelvic jun Terminated |
FAD | K961446 |
| Feb 10, 2009 | Vance Products Incorporated Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a s Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCF-060026-10-13; GPN REF G18131. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070020-14-13; GPN REF G18123. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070018-14-13; GPN REF G18641. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060028-10-13; GPN REF G18120. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent. Terminated |
FAD | K961446 |
| Jan 23, 2009 | Vance Products Incorporated Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060018-10-13; GPN REF G18116.
Ureteral stent. Terminated |
FAD | K961446 |
| Jun 29, 2007 | Vance Products Incorporated Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724. Terminated |
FAD | None listed |