ClearanceBrief
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)
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Top companies in FAD

DateFirm and productCodeLinked 510(k)
Dec 11, 2025C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Open, Classified
FADK043193
Dec 11, 2025C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Open, Classified
FADK043193
Dec 11, 2025C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Open, Classified
FADK043193
Dec 11, 2025C.R. Bard Inc
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Open, Classified
FADK043193
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Open, Classified
FADK834401
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Open, Classified
FADK834401
Jan 4, 2021Cook 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
FADK162109
Nov 16, 2020Boston Scientific Corporation
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Open, Classified
FADK974541
Nov 16, 2020Boston Scientific Corporation
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Open, Classified
FADK974541
Jul 30, 2020Cook 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
FADK151051
K161236
Jan 4, 2019Cook 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
FADK151051
Jan 4, 2019Cook Inc.
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
Terminated
FADK961446
Jan 4, 2019Cook Inc.
Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
Terminated
FADNone listed
Jan 4, 2019Cook Inc.
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Terminated
FADNone listed
Jan 4, 2019Cook Inc.
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Terminated
FADNone listed
Jan 4, 2019Cook Inc.
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Terminated
FADNone listed
Oct 13, 2016C.R. Bard, Inc.
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Terminated
FADK043193
K983498
Oct 13, 2016C.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
FADK043193
Oct 13, 2016C.R. Bard, Inc.
BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Terminated
FADK983498
Oct 13, 2016C.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
FADK823487
Jan 5, 2011Vance 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
FADK961446
May 21, 2009Boston Scientific Corporation
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr Singl
Terminated
FADK820870
May 21, 2009Boston Scientific Corporation
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001221360 I/E-8/22 M00
Terminated
FADK860267
Feb 10, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Jan 23, 2009Vance 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
FADK961446
Sep 16, 2008Applied 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
FADK040760
K060673 +1
Sep 16, 2008Applied 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
FADK040760
K060673 +1
Sep 16, 2008Applied 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
FADK040760
K060673 +1
Sep 16, 2008Applied 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
FADK040760
K060673 +1

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