Vance Products Incorporated
Medical device manufacturer in Spencer, IN.
17510(k) clearances
0PMA approvals
18recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K820313 | Vpi-Fair Urethral StentKOD · Traditional | 03/01/1982SE |
| K812995 | Vance-Jacobellis Microhematuria CatheterKOD · Traditional | 03/01/1982SE |
| K813278 | Vpi Ureteral Dilatation Ballon CatheterEZN · Traditional | 12/18/1981SE |
| K812785 | Vance-Ambrose Resectoscope ForcepsGEN · Traditional | 11/16/1981SE |
| K812057 | Vance CystoscopicFBK · Traditional | 07/31/1981SE |
| K811833 | Vnace Fascial Dilator SetKOE · Traditional | 07/10/1981SE |
| K811454 | Vance Prostatic Aspiration SetKNW · Traditional | 06/09/1981SE |
| K810372 | Vance Deflectable Biopsy Brush SetKOD · Traditional | 03/20/1981SE |
| K810371 | Vance Urethal Dilator SetKOE · Traditional | 03/20/1981SE |
| K810370 | Pollack Chain Cysourethrogram SetFGI · Traditional | 03/20/1981SE |
| K810368 | Vance Percutaneous Malecot NephrostomyKOB · Traditional | 03/20/1981SE |
| K810367 | Kish Urethral Illuminated Catheter SetKOD · Traditional | 03/20/1981SE |
| K803048 | Vance Urostomy ApplianceEXB · Traditional | 12/22/1980SE |
| K792221 | Vance Philips Follower Catheter & BougieKOE · Traditional | 12/06/1979SE |
| K792220 | Vance Kidney Biopsy BrushesKOD · Traditional | 12/06/1979SE |
| K792219 | Vance Malleable Tip FiliformKOE · Traditional | 12/06/1979SE |
| K780765 | Percutaneous Surapubic CatheterKOB · Traditional | 07/17/1978SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0852-2011 | Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R…The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually… | 10/18/2010Terminated |
| Z-0980-2009 | Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating…"Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for… | 11/10/2008Terminated |
| Z-0853-2009 | Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0852-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0851-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0850-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0849-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0848-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0847-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0846-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0845-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0844-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0843-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0842-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0841-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0840-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-0839-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. | 07/31/2008Terminated |
| Z-1168-2007 | Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm…The radiographic band may detach from the stent and remain in the patient after removal of the stent. | 06/29/2007Terminated |