510(k) K961446 ยท FAD Stent, Ureteral
AQ HYDROPHILIC STENT
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, May 28, 1996 |
| Received | Apr 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2019 | Cook Inc. Universa Firm Ureteral Stent, Global Product No. G49864
G49865
G49866
G49867
G49868
G49869
G49870
G49874
G49875
G49877
G49879
G49881
G49882
G49887
G49888 Terminated |
FAD | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.