ClearanceBrief
Product code LJE ยท Class U

Catheter, Nephrostomy

0510(k)s in 12 months (56 all time)
1recalls in 12 months (12 all time)
10recalls that name a 510(k)
Get daily alerts for LJESample briefCSV

Top companies in LJE

Company510(k)sRecalls
Cook Incorporated86
Boston Scientific Corp34
Uresil Corp.50
C.R. Bard, Inc.31
Cook Urological, Inc.40
American Edwards Laboratories30
Manan Medical Products, Inc.30
Medical Engineering Corp.30
Coloplast Corp.20
E-Z-Em, Inc.20
DateFirm and productCodeLinked 510(k)
Nov 20, 2025Olympus Corporation of the Americas
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The N
Open, Classified		 LJEK132383
Sep 5, 2025Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Open, Classified		 LJEK121614
Oct 13, 2021Cook Inc.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipmen
Open, Classified		 LJENone listed
Aug 31, 2020Cook Inc.
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull ti
Terminated		 LJEK181735
Aug 31, 2020Cook Inc.
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm)
Terminated		 LJEK181735
Jan 4, 2019Cook Inc.
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Terminated		 LJEK833762
Oct 12, 2016C.R. Bard, Inc.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mou
Terminated		 LJEK063632
Mar 24, 2016Cook Inc.
Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Ba
Terminated		 LJEK024050
Mar 24, 2016Cook Inc.
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used
Terminated		 LJEK024050
Jul 9, 2013Boston Scientific Corporation
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Terminated		 LJEK121614
Jul 9, 2013Boston Scientific Corporation
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Terminated		 LJEK121614
Jun 5, 2007Boston Scientific Corporation
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Terminated		 LJENone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.