Panels › Gastroenterology, Urology › Product code FAD · Class 2
Stent, Ureteral
Regulation 876.4620
2510(k)s in 12 months (122 all time)
4recalls in 12 months (55 all time)
49recalls that name a 510(k)
Top companies in FAD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit
REF 78826 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit
REF 788630 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit
REF 788426 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit
REF 787614 Open, Classified |
FAD | K043193 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits
Catalog Number: 6108 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits
Catalog Number: 6105 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits
Catalog Number: 6104 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6028 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (contains 3412)
Catalog Number: 6027 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6024 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (containing 6105)
Catalog Number: 6023 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number:6004 Open, Classified |
FAD | K834401 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6001 Open, Classified |
FAD | K834401 |
| Jan 4, 2021 | Cook Inc. Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent
Refere Terminated |
FAD | K162109 |
| Nov 16, 2020 | Boston Scientific Corporation Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 Open, Classified |
FAD | K974541 |
| Nov 16, 2020 | Boston Scientific Corporation Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 Open, Classified |
FAD | K974541 |
| Jul 30, 2020 | Cook Inc. Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder Terminated |
FAD | K151051 K161236 |
| Jan 4, 2019 | Cook Inc. Universa Soft Ureteral Stent, Global Product No. G49887
G49933
G49934
G49937
G49940
G49941
G49942
G49945
G49947
G49948
G49949
G49950
G49951
G49953
G49955
G49956
G49957
G49958
G49959
G49961
G53145
G536 Terminated |
FAD | K151051 |
| 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 | K961446 |
| Jan 4, 2019 | Cook Inc. Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773
G15000
G14867
G14951
G17852 Terminated |
FAD | None listed |
| Jan 4, 2019 | Cook Inc. Sof-Flex Double Pigtail Ureteral Stent
Set, Global Product No. G15076
G14906
G14840
G14865
G17128 Terminated |
FAD | None listed |
| Jan 4, 2019 | Cook Inc. Kwart Retro-Inject Ureteral
Stent Set, Global Product No. G15016
G14836
G14885
G14887
G17151 Terminated |
FAD | None listed |
| Jan 4, 2019 | Cook Inc. C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364
G14365
G14367 Terminated |
FAD | None listed |
| Oct 13, 2016 | C.R. Bard, Inc. Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | K043193 K983498 |
| Oct 13, 2016 | C.R. Bard, Inc. Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | K043193 |
| Oct 13, 2016 | C.R. Bard, Inc. BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | K983498 |
| Oct 13, 2016 | C.R. Bard, Inc. Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent; Bard Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | K823487 |
| 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 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr
Singl Terminated |
FAD | K820870 |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001221360 I/E-8/22
M00 Terminated |
FAD | K860267 |
| 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 |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26cm
Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain throug Terminated |
FAD | K040760 K060673 +1 |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F multilength
Urological stents are disposable sing-use temporary indwelling catheters that allow urine to drain th Terminated |
FAD | K040760 K060673 +1 |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F multilength Urological stents are disposable single-use temporary indwelling catheters that allow urine to dra Terminated |
FAD | K040760 K060673 +1 |
| Sep 16, 2008 | Applied Medical Resources Corp SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain thro Terminated |
FAD | K040760 K060673 +1 |
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